N/A
N=39
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Refractive Errors
Bottom Line
View on ClinicalTrials.gov: NCT04702984 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Front Surface Wettability, by Category — 78; 0; 0; 0 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LID021201 contact lenses (Device); OPTI-FREE multipurpose solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Front Surface Wettability, by Category |
78; 0; 0; 0; 0; 56 | — |
Summary
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
Eligibility Criteria
Inclusion Criteria
- Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
- Successful wear of spherical daily wear frequent 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.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any condition that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Wears 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.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04702984). 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.