N/A
Completed N=113
Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses
Source: ClinicalTrials.gov NCT05725317 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 — -0.13; -0.13 logMAR
Summary
The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4 |
-0.13; -0.13 | — |
Eligibility Criteria
Key Inclusion Criteria
- Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Habitual monovision or multifocal contact lens wearers.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT05725317). 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.