N/A
Completed N=86
Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Refractive Errors
Source: ClinicalTrials.gov NCT03586167 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Distance Visual Acuity (VA) — -0.09; -0.09 logMAR
Summary
The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) |
-0.09; -0.09 | — |
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign an informed consent form approved by an Institutional review board (IRB);
- Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion Criteria
- Any conditions or use of medications that could contraindicate contact lens wear;
- History of or plan to have refractive surgery in either eye;
- Irregular cornea in either eye;
- Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
- 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;
- Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
- Habitual Biofinity contact lens wearers.
Data sourced from ClinicalTrials.gov (NCT03586167). 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.