N/A
N=51
Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT03095027 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Visual Acuity (VA) — -0.08; -0.09; -0.09; -0.09 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID122819 contact lenses (Device); Stenfilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) |
-0.08; -0.09; -0.09; -0.09 | — |
Summary
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign an IRB-approved Informed Consent Form;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
- Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- History of refractive surgery or plan to have refractive surgery during the study;
- Ocular or intraocular surgery within the previous 12 months or planned during the study;
- Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Any previous or current wear of MYDAY;
- Habitually wearing monovision or multifocal lenses during the last 3 months;
- Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03095027). 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.