Status:
COMPLETED
Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
Lead Sponsor:
Alcon Research
Conditions:
Refractive Error
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Spher...
Detailed Description
Two population groups (presbyopes and astigmats) will be enrolled in the study.
Eligibility Criteria
Inclusion
- Must sign an informed consent document;
- Adapted, current soft contact lens wearer with either:
- A spectacle add between +0.50 and +2.50 (inclusive) \[Presbyopes group\]
- A spherical correction of an astigmatism up to 20% of the amount of the sphere \[Astigmats group\];
- Contact lens prescription in the power range specified in the protocol;
- Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
- Willing to wear study lenses up to 12 hours and attend all study visits;
- Can be successfully fitted with study lenses;
- Other protocol-specified inclusion criteria may apply.
Exclusion
- Any 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;
- Use of artificial tears and rewetting drops during the study;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02289742
Start Date
December 1 2014
End Date
March 1 2015
Last Update
July 26 2016
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