Status:
COMPLETED
DAILIES TOTAL1® Lens Centration in a Japanese Population
Lead Sponsor:
Alcon Research
Conditions:
Myopia
Refractive Error
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of weari...
Eligibility Criteria
Inclusion
- Sign Informed Consent document.
- Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
- Symptoms of contact lens discomfort as defined by protocol.
- Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
- Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
- Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
- Acceptable contact lens fit with both study contact lenses.
- Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Currently wearing DT1 or 1DAVTE.
- 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 twelve weeks immediately prior to enrollment for this trial.
- Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
- History of herpetic keratitis, ocular surgery or irregular cornea.
- Prior refractive surgery (e.g. LASIK, PRK, etc).
- Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
- Judged ineligible as a patient in this clinical study by the investigator.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT02252133
Start Date
October 1 2014
End Date
November 1 2014
Last Update
January 29 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Contact Alcon Japan Ltd. for Trial Locations
Tokyo, Japan