N/A
Completed N=15
Clinical Evaluation of Two Monthly Contact Lenses
Source: ClinicalTrials.gov NCT03459131 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Subjective Rating of Overall Vision — 8.6; 8.6 units on a scale
Summary
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Rating of Overall Vision |
8.6; 8.6 | — |
| SECONDARY Over-refraction |
3; 0; 26; 24; 1; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign an approved informed consent form (ICF);
- Successful wear of BIOFINITY® (spherical) (or private label) 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;
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
- Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Current or history of eye injury or disorders, as specified in the protocol;
- Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
- Habitual contact lens wear 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 that would require instillation during contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03459131). 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.