Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

Myopia Clinical Trial

Official title:

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06098339
• Other study ID #: EX-MKTG-151
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of two different monthly replacement lens in habitual spherical soft lens wearers.

Description:

This study is a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant is approximately 3 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. Is at least 18 years of age and no older than 39 years, and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Self-reports having a full eye examination in the previous two years;

5. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

6. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

7. Habitually wears spherical soft contact lenses, for the past 3 months minimum:

It is preferred that all participants are habitual frequent replacement lens wearers. However, if this is not possible then no more than 5 participants can be habitual daily disposable lens wearers at each site, the rest must be habitual frequent replacement lens wearers;

• For the frequent replacement wearers: No more than 3 can be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 can be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;

8. Has refractive astigmatism no higher than -0.75DC in each eye;

9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

3. Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

7. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Lens A (fanfilcon A)
Daily wear for one month
• Lens B (lotrafilcon B)
Daily wear for one month

Locations

Country	Name	City	State
Canada	Insight Eye Care	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling on Removal	Participants will measure subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens will be collected in the at-home diary on Day 27.	Day 27