N/A
Completed N=118
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Source: ClinicalTrials.gov NCT04178720 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Distance VA (logMAR) With Study Lenses - Completed Eyes — -0.07; -0.07; -0.08; -0.07 logMAR
Summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance VA (logMAR) With Study Lenses - Completed Eyes |
-0.07; -0.07; -0.08; -0.07; -0.07; -0.07 | — |
| PRIMARY Distance VA (logMAR) With Study Lenses - Discontinued Eyes |
-0.06; 0.00; -0.12; -0.12; 0.00; -0.12 | — |
Eligibility Criteria
Key Inclusion Criteria
- Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- 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.
- Habitually wearing Biofinity contact lenses.
- Monovision contact lens wearers.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04178720). 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.