Status:
COMPLETED
Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
Lead Sponsor:
Alcon Research
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
18-44 years
Phase:
NA
Brief 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). Secondaril...
Detailed Description
Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01839318
Start Date
April 1 2013
End Date
June 1 2013
Last Update
June 20 2014
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