Status:
COMPLETED
Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
Lead Sponsor:
Alcon Research
Conditions:
Myopia
Ametropia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives ...
Eligibility Criteria
Inclusion
- Sign Informed Consent Document.
- Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
- Currently wear soft contact lenses.
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
- Manifest cylinder less than or equal to 1.00 D.
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
- Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
- History of corneal or refractive surgery.
- Biomicroscopy findings greater than Grade 2 at baseline.
- A pathologically dry eye that precludes contact lens wear.
- Monocular (only one eye with functional vision).
- Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
- History of intolerance or hypersensitivity to any component of the investigational products.
- Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01797783
Start Date
February 1 2013
End Date
April 1 2013
Last Update
May 23 2014
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