A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution

• Status: Not yet recruiting
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed

2. Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations

3. Is a habitual wearer (at least 3 months)

4. Has typically cleaned and disinfected their pre-study contact lenses daily

5. Has typically replaced their pre-study contact lenses monthly

6. Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart

7. Has clear central corneas and is free of any anterior segment disorders

8. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses

9. Requires lens correction in both eyes

10. Wears the same manufacturer and brand of lens in both eyes

11. Agrees to wear study lenses on a daily wear basis for approximately three months

12. Is willing and able to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

1. Is currently using a hydrogen-peroxide cleaning and disinfecting solution

2. Participated in any drug or device clinical investigation within 30 days prior to entry into this study

3. Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:

• they are currently pregnant

• they plan to become pregnant during the study

• they are breastfeeding

4. Has worn gas permeable (GP) lenses within the last 30 days

5. Has worn polymethylmethacrylate (PMMA) lenses within the last three months

6. Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year

7. Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study

8. Has any ocular disease, or is using any ocular medication.

9. Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance

10. Currently wears monovision, multifocal, or toric contact lenses

11. Has ocular astigmatism of 1.00D or greater in either eye

12. Has anisometropia (spherical equivalent) of greater than 2.00D

13. Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)

14. Has corneal infiltrates, of ANY GRADE

15. Has any "Present" ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear

16. Has any scar or neovascularization within the central 6 mm of the cornea, irregular cornea or a history of herpetic keratitis

◊ Note that subjects with minor peripheral corneal scarring (that does not extend into the 6 mm central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.

17. Is aphakic

18. Is amblyopic

19. Has had any corneal surgery (e.g., refractive surgery)

20. Is allergic to any component in the study care products.

21. Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household

22. Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties

23. Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.