Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Lens B; Device: Lens A

• Registration Number: NCT05516082
• Lead Sponsor: Coopervision, Inc.

Brief Summary

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Detailed Description

The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Study Timeline

• Study Start: 2022-08-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Status Verified: 2022-10
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Results First Submitted: 2023-10-11
• Results First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Results First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 the required time of the study.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has refractive astigmatism no higher than -0.75 DC.
• Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
• Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

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	15 minutes	Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.

Trial Locations

Locations (1)

Dr. Ruben Velazquez Private Practice; 🇲🇽 Mexico City, Mexico