N/A
N=28
Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
Myopia · Hyperopia · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01839318 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours — 5.28; 3.46; 4.93 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A contact lenses (Device); Omafilcon A contact lenses (Device); Etafilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours |
5.28; 3.46; 4.93 | — |
| SECONDARY Total Wettability Score |
0.74; 0.83; 0.84; 1.25; 1.20; 1.42 | — |
Summary
The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent.
- Adapted soft contact lens wearer.
- Willing to wear contact lenses up to 12 hours and attend all study visits.
- Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
- Contact lens prescription within the power range specified in the protocol.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Any use of systemic or ocular medications that would contraindicate contact lens wear.
- Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
- Monocular (only 1 eye with functional vision) or fit with only 1 lens.
- History of herpetic keratitis, ocular surgery, or irregular cornea.
- Known pregnancy.
- Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01839318). 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.