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

NCT ID: NCT06098339

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-04-04

Brief Summary

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Detailed Description

This study was 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 was approximately 3 months.

Conditions

Myopia; Hyperopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lens A, then Lens B

Participants wore Lens A for one month and then Lens B for one month.

Group Type: EXPERIMENTAL

Lens A (fanfilcon A)

Intervention Type: DEVICE

Daily wear for one month

Lens B (lotrafilcon B)

Intervention Type: DEVICE

Daily wear for one month

Lens B, then Lens A

Participants wore Lens B one month and then Lens A for one month.

Group Type: EXPERIMENTAL

Lens A (fanfilcon A)

Intervention Type: DEVICE

Daily wear for one month

Lens B (lotrafilcon B)

Intervention Type: DEVICE

Daily wear for one month

Interventions

Lens A (fanfilcon A)

Daily wear for one month

Intervention Type: DEVICE

Lens B (lotrafilcon B)

Daily wear for one month

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

2. Had read and signed an information consent letter;

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

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

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

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

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

It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

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

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

9. Could 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. Were participating in any concurrent clinical or research study;

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

3. Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;

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

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

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

7. Had undergone refractive error surgery or intraocular surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn MacNeil

Role: PRINCIPAL_INVESTIGATOR

Insight Eye Care

Abigail Gillogly-Harsch

Role: PRINCIPAL_INVESTIGATOR

Nittany Eye Associates

Roxanne Achong-Coan

Role: PRINCIPAL_INVESTIGATOR

Coan Eye Care

Locations

Coan Eye Care

Ocoee, Florida, United States

Nittany Eye Associates

State College, Pennsylvania, United States

Insight Eye Care

Waterloo, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-151

Identifier Type: -

Identifier Source: org_study_id