N/A
N=29
DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02517567 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Tear Film Evaporation Rate — 120.88; 105.63 gm^-2 h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A contact lenses (Device); Narafilcon A contact lenses (Device); Somofilcon A contact lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Evaporation Rate |
120.88; 105.63 | — |
Summary
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.
Eligibility Criteria
Inclusion Criteria
- Sign an informed consent document;
- Adapted, current soft contact lens wearer;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- Can be successfully fitted with study lenses;
- Willing to wear lenses for a minimum of 8 hours prior to each study visit;
- Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only one lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Known pregnancy and lactation;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02517567). 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.