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

Refractive Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565937
• Other study ID #: 914
• Status: Completed
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: June 2023
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
• renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses

Locations

Country	Name	City	State
United States	The Eyecare Studio, LLC	Decatur	Georgia
United States	Chester T Roe III MD Prof LLC	Denver	Colorado
United States	Biopharma Informatic	Houston	Texas
United States	Spectrum Eyecare	Jamestown	New York
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Optometric Physicians of Middle Tennessee	Nashville	Tennessee
United States	Eola Eyes	Orlando	Florida
United States	Kannarr EyeCare	Pittsburg	Kansas
United States	Casco Bay EyeCare	Portland	Maine
United States	Oculus Research	Raleigh	North Carolina
United States	Advanced Eye Care, PC	Raytown	Missouri
United States	Koetting Associates	Saint Louis	Missouri
United States	Eric White OD Inc	San Diego	California
United States	Lee & Woo Optometry	San Francisco	California
United States	Golden Vision	Sarasota	Florida
United States	Saccco Eye Group	Vestal	New York
United States	Berlin Eyecare Associates	W. Berlin	New Jersey
United States	InSight Eyecare	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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