(106 days)
P830034/S016
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a lubricating eye drop solution, with no mention of AI or ML technology.
No
The device is indicated for lubricating and rewetting contact lenses, which typically addresses symptoms like dryness or discomfort, rather than treating a disease or restoring a function.
No
The "Intended Use / Indications for Use" states that the drops are for lubricating and rewetting contact lenses, not for diagnosing any condition.
No
The device description clearly states it is a sterile, preservative-free, buffered, isotonic, aqueous solution, which is a physical substance (liquid) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and rewet contact lenses during wear. This is a direct interaction with the contact lens and the eye, not a test performed on a sample taken from the body.
- Device Description: The description details a sterile, buffered, isotonic aqueous solution for lubricating and rewetting contact lenses. This is consistent with a topical ophthalmic solution for contact lens care.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue. The device's function is purely to improve comfort and wearability of contact lenses.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear. When used 4 times a day, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops helps prevent deposit build-up on lenses. Bausch + Lomb Preservative Free Lubricating and Rewetting Drops may be supplied in a foil pouch containing sterile Single Use Dispensers or in Multi-Dose bottles. The dispenser, foil pouch, bottles and cartons are marked with a lot number and expiration date.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 - 63 years (Test group); 18 - 65 years (Control group)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 369 subjects were enrolled in a one month multicenter, randomized, masked, parallel, bilateral study conducted in the USA. Subjects were randomized to receive investigational Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (Test), or OPTI-FREE Replenish Rewetting Drops (Control). Eligible subjects were enrolled into one of eight lens groups based on their habitual contact lenses. In total, 365 of the 369 subjects enrolled completed the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1. 1997.
Biocompatibility:
Studies were performed to assess the biocompatibility of the product, primary packaging, and biological safety of the formulation over shelf life. Testing was conducted on product packaged in both configurations under various conditions: formulation alone, formulation with marketed contact lenses, and primary packaging components. Testing was also conducted at end of shelf life. Biological testing was previously conducted on Multi-Dose Unit LDPE bottles, including in vitro cytotoxicity, in vivo acute systemic toxicity, intracutaneous irritation, muscle implantation, and sensitization. Ocular Irritation testing was also performed. Single Dose Unit Dispensers leveraged previous testing cleared under K200416. In vitro cytotoxicity testing was conducted on the formulation with various types of contact lenses. The passing results demonstrate biocompatibility and biological safety over shelf life.
Microbiology:
Single Dose Unit (SDU) testing was conducted in accordance with FDA guidance requirements. The package integrity and tip seal effectiveness of the Multi-Dose Unit configuration were evaluated using Tip Seal, Tip Contamination, and Aerosol Challenge Testing. All testing demonstrated a robust tip seal barrier with no microbial ingress, even after simulated in-use over 90 days.
Lens Compatibility:
Results of lens compatibility studies demonstrate that the product is compatible with soft contact lenses, including silicone hydrogel contact lenses, rigid gas permeable, silicone acrylate (SA), and fluorosilicone acrylate (FSA) lenses.
Clinical Study:
A controlled clinical study was conducted with 369 subjects (365 completed) in a one-month multicenter, randomized, masked, parallel, bilateral study in the USA. Subjects were randomized to receive Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (Test group, 188 subjects) or OPTI-FREE Replenish Rewetting Drops (Control group, 181 subjects).
- Safety Results: The primary endpoint for slit lamp findings achieved non-inferiority for the test device compared to the predicate for findings greater than Grade 2. Five ocular treatment-emergent adverse events (TEAEs) were reported in the test group (eye irritation, eye pruritus, eye complication associated with ocular discomfort), all of which resolved with no action required and no discontinuations. No TEAEs were reported in the control group. No corneal infiltrates or changes to pre-existing corneal scars were reported. Visual acuities were similar between groups. The device was deemed safe for use with various contact lenses.
- Effectiveness Results: For the three primary effectiveness endpoints (overall comfort, dryness, and optimal lens deposits averaged over all follow-up visits), the test device was non-inferior to the predicate solution. No notable differences were found in additional effectiveness assessments (symptoms/complaints, worn lens characteristics, dispensed lens characteristics). The device was deemed effective for use with various contact lenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P830034/S016
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
December 06, 2022
Bausch & Lomb Incorporated Melissa Thomas Director, Regulatory Affairs 1400 N Goodman Street Rochester, NY 14609
Re: K222541
Trade/Device Name: Bausch + Lomb Preservative Free Lubricating and Rewetting Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: November 4, 2022 Received: November 7, 2022
Dear Melissa Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J Angelo Green -S
Image /page/1/Picture/6 description: The image shows the letters FDA in a large, sans-serif font. The letters are light blue and appear to be slightly faded. The background is white.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Indications for Use (Describe)
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
| 1. General Information | |
|---|---|
| Submitter: | Contact Person: |
| Bausch & Lomb Incorporated | Melissa Thomas |
| 1400 North Goodman Street | 1400 North Goodman Street |
| Rochester, NY 14609 | Rochester, NY 14609 |
| General Telephone: 585-338-5800 | 585-338-6045 (phone) |
| 585-338-0702 (fax) | |
| Melissa.Thomas@bausch.com |
Premarket Notification Number: K222541
November 4, 2022 Preparation Date:
2. Device Identification
| Device Name: | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops |
|---|---|
| Classification Name: | Soft hydrophilic contact lens care product (21 CFR §886.5928), |
| Rigid gas permeable contact lens care product (21 CFR §886.5918) | |
| Common Name: | Soft (hydrophilic) contact lens care solution |
| Rigid gas permeable contact lens care products | |
| Product Codes: | LPN, MRC |
Device Classification: Class II
3. Predicate Device
P830034/S016 OPTI-FREE Replenish Rewetting Drops approved on November 21, 1990 is a sterile, buffered, isotonic, aqueous solution that contains a citrate/borate buffer and sodium chloride with edetate disodium 0.05% and POLYQUAD* (polyquaternium-1) 0.001% as preservatives and RLM-100 (PEG-11 lauryl ether carboxylic acid) and TETRONIC®1 1304.
4. Product Description
The subject of this 510(k) submission is for the new product, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, which is substantially equivalent to the currently commercialized OPTI-FREE Replenish Rewetting Drops.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic)
4
contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.
When used 4 times a day, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops helps prevent deposit build-up on lenses.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops may be supplied in a foil pouch containing sterile Single Use Dispensers or in Multi-Dose bottles. The dispenser, foil pouch, bottles and cartons are marked with a lot number and expiration date.
5. Indications for Use
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
6. Summary of Technological Characteristics
The technological characteristics of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are substantially equivalent to those of the predicate device.
| Features | Predicate Device
OPTI-FREE Replenish Rewetting
Drops | Subject Device
Bausch + Lomb Preservative Free
Lubricating and Rewetting Drops |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | P830034/S016 | To be assigned |
| Classification | | |
| Classification | Class II | Class II |
| Product Code | LPN | LPN, MRC |
| Indication | | |
| Indicated for Soft
Contact Lenses | Yes | Yes |
| Indicated for
Silicone
Hydrogel Lenses | Yes | Yes |
| Indicated for
Rigid Gas
Permeable
Lenses | Yes | Yes |
| Intended Use | Indicated to lubricate and rewet
daily, extended wear and disposable
soft (hydrophilic) contact lenses and
fluorosilicone acrylate and silicone
acrylate, gas permeable and silicone
hydrogel contact lenses as follows:
• Moisturizing lenses as needed
during the day to reduce discomfort. | Bausch + Lomb Preservative Free
Lubricating and Rewetting Drops
are indicated for use to lubricate and
rewet soft (hydrophilic) contact
lenses, including silicone hydrogel
as well as silicone acrylate (SA) and
fluorosilicone acrylate (FSA) rigid
gas permeable (RGP) contact lenses |
Table 1: Comparison of Characteristics
5
| | • Moisturizing extended wear lenses
prior to retiring at night and upon
awakening. | during wear. The product may be
used with daily or extended wear,
and disposable lenses. |
|-------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Formulation / Regimen | | |
| Deposit buildup
prevention | Place 2 drops in each eye and blink
2-3 times, 4 times a day. | To help prevent deposit buildup:
Place 2 drops in each eye and blink
2-3 times, 4 times a day. |
| Preservatives | POLYQUAD* | None |
| Surfactant | Tetronic 1304 | Poloxamine 1107 |
| Storage | Store at room Temperature | Store at room Temperature |
| Discard Date | None noted in labeling | 90 days (Multi-Dose Unit)
Immediately after use (Single Dose
Unit) |
| Primary
Container | White Plastic Bottle, white cap | Natural LDPE** Bottle, natural cap
or
Natural LDPE dispenser |
| Tamper
Resistant | Yes | Yes, Tamper Evident Pull Strip
(Multi-Dose Unit) |
*Polyquaternium-1
**Low Density Polyethylene
7. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is substantially equivalent to the predicate device.
8. Performance Data
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1. 1997. A brief summary of the test results is provided below:
Biocompatibility
Bausch + Lomb performed a series of studies to assess the biocompatibility of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, the primary packaging, and the biological safety of the formulation over shelf life in accordance with FDA Guidance Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.
Biocompatibility testing was conducted on product packaged in both configurations under various conditions. Testing was performed on the formulation alone, the formulation in conjunction with marketed contact lenses, and the primary packaging components including the formulation-
6
contacting components of the multi-dose dispenser. In addition, testing was conducted at end of shelf life.
Biological testing was previously conducted on the formulation-contacting components of the Multi-Dose Unit, including in vitro cytotoxicity and in vivo acute systemic toxicity, intracutaneous irritation, muscle implantation and sensitization. Additionally, Bausch + Lomb conducted Ocular Irritation testing.
Bausch + Lomb evaluated the biocompatibility of the Multi-Dose Unit LDPE bottles in in vitro cytotoxicity, in vivo systemic toxicity and acute ocular irritation studies.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops Single Dose Unit Dispensers uses identical packaging materials previously cleared under K200416. Therefore, testing previously conducted on the Single Dose Unit dispensers was leveraged to support biocompatibility.
The Bausch + Lomb Preservative Free Lubricating and Rewetting Drops formulation alone has been assessed for biocompatibility in in vitro cytotoxicity, and in vivo acute and repeated dose ocular irritation studies.
In vitro cytotoxicity testing was conducted on the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops formulation in conjunction with marketed traditional soft contact lenses, silicone hydrogel contact lenses, silicone acrylate and fluorosilicone acrylate rigid gas permeable contact lenses. Additionally, in vivo ocular irritation studies were conducted with representative silicone acrylate and fluorosilicone acrylate rigid gas permeable lenses and soft contact lenses, which evaluated the formulation in both packaging configurations with and without contact lens wear following repeated topical ocular administration.
The passing results of the testing demonstrate the Biocompatibility and Biological Safety over shelf life of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops.
Microbiology
Single Dose Unit (SDU) testing was conducted in accordance with FDA Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products May 1997 requirements Section III.E, "Product Specific Guidance In-Eye Contact Lens Solutions (e.g., Lubricating and/or Rewetting Drops)".
The package integrity and tip seal effectiveness of the Multi-Dose Unit configuration was evaluated using Tip Seal, Tip Contamination and Aerosol Challenge Testing. All testing demonstrated a robust tip seal barrier as no microbial ingress was apparent as evidenced by testing of the container contents for microbial growth. Tip Seal and Aerosol Challenge testing after simulated in use over a minimum of 90 days demonstrated an integrous robust tip seal barrier.
Lens Compatibility
The results of lens compatibility studies demonstrate Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is compatible with soft contact lenses including silicone hydrogel contact lenses, rigid gas permeable, silicone acrylate ((SA), and fluorosilicone acrylate (FSA)) lenses.
7
Clinical Study
Bausch + Lomb conducted a controlled clinical study with soft (hydrophilic) contact lenses, including silicone hydrogel lenses, silicone acrylate (SA), and fluorosilicone acrylate (FSA) lenses, comparing the safety and effectiveness of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops to OPTI-FREE Replenish Rewetting Drops. The results of the study support a substantial equivalence determination.
A total of 369 subjects were enrolled in a one month multicenter, randomized, masked, parallel, bilateral study conducted in the USA. Subjects were randomized to receive investigational Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (Test), or OPTI-FREE Replenish Rewetting Drops (Control). Eligible subjects were enrolled into one of eight lens groups based on their habitual contact lenses. In total, 365 of the 369 subjects enrolled completed the study.
Subject Demographics
Of the 188 subjects in the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops group, 60 (31.9%) were male and 128 (68.1%) were female, with a mean (SD) age of 35.6 (9.56) years (range: 18 - 63 years). Of the 181 subjects in the OPTI-FREE Replenish Rewetting Drops group, 57 (31.5%) were male and 124 (68.5%) were female, with a mean (SD) age of 33.7 (8.57) years (range: 18 - 65 years).
With regard to race, in the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops group 144 (76.6%) subjects were White, 18 (9.6%) were Black/African American, 24 (12.8%) were Asian, and 2 (1.1%) was Multiple. In the OPTI-FREE Replenish Rewetting Drops group 130 (71.8%) subjects were White, 21 (11.6 %) were Black/African American. 27 (14.9%) were Asian, 1 (0.6%) was Native Hawaiian or Other Pacific Islander and 2 (1.1 %) was Multiple.
Safety Results
The primary endpoint of interest for slit lamp findings was achieved. The Bausch + Lomb Preservative Free Lubricating and Rewetting Drops group demonstrated noninferiority to the OPTI-FREE Replenish Rewetting Drops group Over All Follow-up Visits for slit lamp findings greater than Grade 2.
In the test device Bausch + Lomb Preservative Free Lubricating and Rewetting Drops there were five ocular treatment-emergent adverse events (TEAEs) reported in three eyes of two subjects. The five ocular TEAEs were eye irritation (2), eye pruritus (2) and eye complication associated with ocular discomfort with device (contact lens) (1). Four eye irritation and eye pruritus adverse events occurred simultaneously in a single subject. All five ocular TEAEs resolved with no action required, and there were no eyes discontinued from the study due to an adverse event (AE). In the control group using OPTI-FREE Replenish Rewetting Drops there were no TEAEs.
There were no corneal infiltrates reported and no changes to pre-existing corneal scars. There were no notable differences between the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops and OPTI-FREE Replenish Rewetting Drops groups for any of the lens wear or lens performance parameters at any of the study visits. Visual acuities were similar between eyes of both groups.
8
In conclusion, graded slit lamp findings, the comparison of AEs, and the comparison of visual acuities indicate that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is safe for use with soft contact lenses, including silicone hydrogel lenses as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses.
Effectiveness Results
For each of the three primary effectiveness endpoints (overall comfort averaged over all followup visits; dryness averaged over all follow-up visits; and optimal [none or light] lens deposits at all follow-up visits), the treatment differences indicated that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is non-inferior to the OPTI-FREE Replenish Rewetting Drops solution. There were no notable differences between the two treatment groups with regard to the additional effectiveness assessments of symptoms/complaints, worn lens characteristics, and dispensed lens characteristics. In conclusion, the three primary effectiveness endpoints indicate that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is effective for use with soft contact lenses, including silicone hydrogel lenses as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lens.
Substantial Equivalence
The cumulative results of laboratory, in vivo, and clinical testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are substantially equivalent to OPTI-FREE Replenish Rewetting Drops for soft contact lenses, including silicone hydrogel contact lenses as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lens.