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

Not Applicable

Completed

• Conditions: Refractive Ametropia
• Interventions: Device: renu® Advanced Formula multi-purpose solution; Device: BL-3100-NBR03 multi-purpose solution

• Registration Number: NCT05565937
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Study Start: 2023-04-12
• Status Verified: 2023-06
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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. 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
6. Has clear central corneas and is free of any anterior segment disorders
7. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
8. Requires lens correction in both eyes
9. Wears the same manufacturer and brand of lens in both eyes
10. Agrees to wear study lenses on a daily wear basis for approximately three months
11. Is willing and able to comply with all treatment and follow-up/study procedures.

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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. Subjects with an active ocular disease, or who are 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 typically worn their pr-study control lenses on an extended wear bases, sleeping on their lenses one night or more per week, during the last year.

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renu® Advanced Formula	renu® Advanced Formula multi-purpose solution	renu® Advanced Formula multi-purpose solution
BL-3100-NBR03	BL-3100-NBR03 multi-purpose solution	BL-3100-NBR03 multi-purpose solution

Primary Outcome Measures

Name	Time	Method
Overall comfort averaged over all scheduled follow-up visits	3 months	Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
The proportion of eyes with a maximum degree of front surface deposits grade of < 2 over all scheduled follow-up visits	3 months	The degree of front surface deposits will be graded for each eye as 0, 1, 2, 3, or 4.
The proportion of eyes with any slit-lamp findings greater than Grade 2 over all follow-up visits.	3 months	Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
Vision averaged over all scheduled follow-up visits	3 months	Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response

Trial Locations

Locations (19)

Casco Bay EyeCare; 🇺🇸 Portland, Maine, United States

Lee & Woo Optometry; 🇺🇸 San Francisco, California, United States

Optometric Physicians of Middle Tennessee; 🇺🇸 Nashville, Tennessee, United States

Biopharma Informatic; 🇺🇸 Houston, Texas, United States

Chester T Roe III MD Prof LLC; 🇺🇸 Denver, Colorado, United States

Eric White OD Inc; 🇺🇸 San Diego, California, United States

Eola Eyes; 🇺🇸 Orlando, Florida, United States

The Eyecare Studio, LLC; 🇺🇸 Decatur, Georgia, United States

Golden Vision; 🇺🇸 Sarasota, Florida, United States

Kannarr EyeCare; 🇺🇸 Pittsburg, Kansas, United States

Complete Eye Care of Medina; 🇺🇸 Medina, Minnesota, United States

Advanced Eye Care, PC; 🇺🇸 Raytown, Missouri, United States

InSight Eyecare; 🇺🇸 Warrensburg, Missouri, United States

Koetting Associates; 🇺🇸 Saint Louis, Missouri, United States

Spectrum Eyecare; 🇺🇸 Jamestown, New York, United States

Berlin Eyecare Associates; 🇺🇸 W. Berlin, New Jersey, United States

Saccco Eye Group; 🇺🇸 Vestal, New York, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States

Oculus Research; 🇺🇸 Raleigh, North Carolina, United States