N/A
Completed N=36
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Refractive Errors
Source: ClinicalTrials.gov NCT04789382 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Average Percent Area of Corneal Staining — 2.93; 0.45; 6.06; 3.52 percentage of area
Summary
The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percent Area of Corneal Staining |
2.93; 0.45; 6.06; 3.52 | — |
Eligibility Criteria
Key Inclusion Criteria
- Understand and sign an Informed Consent;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Eye surgery, as specified in the protocol;
- Dry eye; use of artificial tears, as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04789382). 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.