Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Not Applicable

Completed

• Conditions: Myopia; Hyperopia
• Interventions: Device: Lens B; Device: Lens A

• Registration Number: NCT05656885
• Lead Sponsor: Coopervision, Inc.

Brief Summary

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Detailed Description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Study Timeline

• Study Start: 2022-09-27
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-19
• Results First Submitted: 2023-11-09
• Results First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Results First Posted: 2023-12-27
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and signed an information consent letter.
• Self-reports having a full eye examination in the previous two years.
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens B	Lens B	All participants wore Lens B for 15 minutes (Period 2)
Lens A	Lens A	All participants wore Lens A for 15 minutes (Period 1)

Primary Outcome Measures

Name	Time	Method
Lens Fit Acceptance Rating	15 minutes	Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator.

Trial Locations

Locations (1)

University Complutense of Madrid; 🇪🇸 Madrid, Spain