Status:
COMPLETED
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Lead Sponsor:
Alcon Research
Conditions:
Presbyopia
Refractive Error
Eligibility:
All Genders
41-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
Detailed Description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next...
Eligibility Criteria
Inclusion
- History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
- Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
- Requiring lenses within the power range of both study contact lenses to be fitted
- Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
- Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
- Acceptable fit with both study contact lenses
- Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
- Other protocol-defined inclusion criteria may apply
Exclusion
- Current multifocal contact lens wearer
- Current monovision wearer or failed attempt with monovision
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
- Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
- Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
- History of herpetic keratitis, ocular surgery or irregular cornea
- Prior refractive surgery (e.g. LASIK, PRK, etc)
- Monocular (only 1 eye with functional vision) or fit with only 1 lens
- Habitually uncorrected anisometropia \>2.00D
- Clinically significant anisocoria
- Participation in any clinical trial within 30 days of the enrollment visit
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02235831
Start Date
September 1 2014
End Date
October 1 2014
Last Update
July 11 2016
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