Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

NCT ID: NCT05035017

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2021-07-31

Brief Summary

The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

Detailed Description

This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Conditions

Myopia

Study Design

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

Study Groups

Test Lens, then Control Lens

Participants wore Test Lens for 2 days, and then Control Lens for 2 days

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

Daily disposable with modified lens design for 2 days

Control Lens

Intervention Type: DEVICE

Daily disposable lens for 2 days

Control Lens, then Test Lens

Participants wore Control Lens for 2 days, and then Test Lens for 2 days

Group Type: ACTIVE_COMPARATOR

Test Lens

Intervention Type: DEVICE

Daily disposable with modified lens design for 2 days

Control Lens

Intervention Type: DEVICE

Daily disposable lens for 2 days

Interventions

Test Lens

Daily disposable with modified lens design for 2 days

Intervention Type: DEVICE

Control Lens

Daily disposable lens for 2 days

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
• Wears CLs in both eyes (monovision acceptable, but not monofit)
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination
• Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.

Exclusion Criteria

• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any concomitant systemic or topical medications that will affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye-related clinical or research study.

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

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana University School of Optometry

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-20-63

Identifier Type: -

Identifier Source: org_study_id