N/A
N=35
Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT05035017 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Overall Comfort With Lens — 86; 72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Lens (Device); Control Lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort With Lens |
86; 72 | — |
| SECONDARY Overall Vision Quality |
90; 91 | — |
| SECONDARY Overall Lens Fit Acceptance |
3.11; 3.09 | — |
| SECONDARY Overall Lens Handling |
88; 87 | — |
| SECONDARY Anterior Ocular Health - Corneal Staining Extent |
0.10; 0.16; 0.11; 0.14; 0.10; 0.13 | — |
Summary
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
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.
Data sourced from ClinicalTrials.gov (NCT05035017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.