N/A
Completed N=132
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Refractive Errors · ametropia
Source: ClinicalTrials.gov NCT04532099 ↗
Enrolled (actual)
132
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Distance Visual Acuity (VA) (Part A) — -0.12; -0.12 logMAR
Summary
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) (Part A) |
-0.12; -0.12 | — |
Eligibility Criteria
Key Inclusion Criteria
- Sign an approved Informed Consent Form.
- Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Routinely sleeps in contact lenses at least 1 night per week.
- Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
- Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04532099). 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. Informational only — not medical advice.