Mode
Text Size
Log in / Sign up
N/A N=35 Randomized Double-blind Treatment

Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

Myopia

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search