Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers

Myopia Clinical Trial

Official title:

Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114564
• Other study ID #: EX-MKTG-129
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: April 22, 2022

Study information

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

Clinical Trial Summary

The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.

Description:

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;

• Has read and signed an information consent letter;

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

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

• Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;

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

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

• Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;

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

• 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:

• Is participating in any concurrent clinical or research study;

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

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

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

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

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

• Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Lens A (comfilcon A lens)
1 month
• Lens B (lehfilcon A lens)
1 month

Locations

Country	Name	City	State
United States	Athens Eye Care	Athens	Ohio
United States	ProCare Vision Center	Granville	Ohio
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Sacco Eye Group	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Ratings on Lens Handling on Removal	Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)	Day 27