Clinical trial NCT05565937: A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
Official title: A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Ametropia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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. 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.

Primary outcomes:
measure: Overall Comfort Averaged Over All Follow-up Visits
timeFrame: Assessed at all follow-up visits through 3 months.
measure: Vision Averaged Over All Follow-up Visits
timeFrame: Assessed at all follow-up visits through 3 months.
measure: The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
timeFrame: Assessed at all follow-up visits through 3 months.
measure: The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
timeFrame: Assessed at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Eric White OD Inc
state: California
city: San Francisco
country: United States
facility: Lee & Woo Optometry
state: California
city: Denver
country: United States
facility: Chester T Roe III MD Prof LLC
state: Colorado
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Decatur
country: United States
facility: The Eyecare Studio, LLC
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr EyeCare
state: Kansas
city: Portland
country: United States
facility: Casco Bay EyeCare
state: Maine
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
city: Raytown
country: United States
facility: Advanced Eye Care, PC
state: Missouri
city: Saint Louis
country: United States
facility: Koetting Associates
state: Missouri
city: Warrensburg
country: United States
facility: InSight Eyecare
state: Missouri
city: W. Berlin
country: United States
facility: Berlin Eyecare Associates
state: New Jersey
city: Jamestown
country: United States
facility: Spectrum Eyecare
state: New York
city: Vestal
country: United States
facility: Saccco Eye Group
state: New York
city: Raleigh
country: United States
facility: Oculus Research
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Optometric Physicians of Middle Tennessee
state: Tennessee
city: Houston
country: United States
facility: Biopharma Informatic
state: Texas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Daniel Donatello
role: STUDY_DIRECTOR
References: