N/A
Completed N=147
Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
Source: ClinicalTrials.gov NCT04422990 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up — -0.06; -0.06 logMAR
Summary
The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up |
-0.06; -0.06 | — |
| SECONDARY Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up |
98.8; 97.0 | — |
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;
- Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;
- Other protocol-defined 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 lenses;
- Monovision or multifocal contact lens wearers;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04422990). 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.