A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens
|ClinicalTrials.gov Identifier: NCT01192126|
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : January 3, 2014
Last Update Posted : January 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myopia Contact Lenses||Device: Bausch & Lomb new daily disposable Device: Johnson & Johnson Acuvue Moist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Bausch & Lomb new daily disposable
New daily disposable contact lenses
Device: Bausch & Lomb new daily disposable
Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Active Comparator: Johnson & Johnson Acuvue Moist
Device: Johnson & Johnson Acuvue Moist
Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
- Visual Acuity [ Time Frame: Dispensing Visit and 1 week follow-up ]Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.
- Slit Lamp Examination > Grade 2 [ Time Frame: All study visits from screening through 2 week follow-up ]Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192126
|United States, New York|
|Bausch & Lomb|
|Rochester, New York, United States, 14609|
|Study Director:||Bev Barna||Bausch & Lomb Incorporated|