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

NCT06098339 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-151
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• Lens Handling on Removal

  Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

  Day 27

Study Arms (2)

Lens A, then Lens B

EXPERIMENTAL

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

Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)

Lens B, then Lens A

EXPERIMENTAL

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

Device: Lens A (fanfilcon A); Device: Lens B (lotrafilcon B)

Interventions

Lens A (fanfilcon A) DEVICE

Daily wear for one month

Lens A, then Lens B; Lens B, then Lens A

Lens B (lotrafilcon B) DEVICE

Daily wear for one month

Lens A, then Lens B; Lens B, then Lens A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
• Had read and signed an information consent letter;
• Were willing and able to follow instructions and maintain the appointment schedule;
• Self-reported having had a full eye examination in the previous two years;
• Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
• Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
• 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;
• Had refractive astigmatism no higher than -0.75DC in each eye;
• 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).

You may not qualify if:

• Were participating in any concurrent clinical or research study;
• Had any known active ocular disease and/or infection that contraindicated contact lens wear;
• Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
• 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;
• Had known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Had undergone refractive error surgery or intraocular surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (3)

Coan Eye Care

Ocoee, Florida, 34761, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

Insight Eye Care

Waterloo, Ontario, N2L 3S1, Canada

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega, O.D., MSc., PhD, FAAO
• Organization: CooperVision Inc.

JVega2@coopervision.com

925-621-3761

Study Officials

• Carolyn MacNeil

  Insight Eye Care

  PRINCIPAL INVESTIGATOR

• Abigail Gillogly-Harsch

  Nittany Eye Associates

  PRINCIPAL INVESTIGATOR

• Roxanne Achong-Coan

  Coan Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: November 13, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: August 28, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)