N/A
N=36
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT04055519 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Distance VA (logMAR) With Study Lenses — -0.13; -0.14 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lehfilcon A contact lenses (Device); Comfilcon A contact lenses (Device); Multi-purpose disinfection solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance VA (logMAR) With Study Lenses |
-0.13; -0.14 | — |
Summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent document.
- Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any eye condition or disease or use of medication that contraindicates contact lens wear.
- Eye surgery, irregular cornea, eye injury as specified in the protocol.
- Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- Habitually wears Biofinity contact lenses.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04055519). 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.