Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
|ClinicalTrials.gov Identifier: NCT01839318|
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : June 20, 2014
Last Update Posted : June 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myopia Hyperopia Refractive Error||Device: Nelfilcon A contact lenses Device: Omafilcon A contact lenses Device: Etafilcon A contact lenses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: DAILIES AquaComfort Plus
Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
Device: Nelfilcon A contact lenses
Other Name: DAILIES® AquaComfort Plus®
Active Comparator: 1-DAY ACUVUE MOIST
Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.
Device: Etafilcon A contact lenses
Other Name: 1-DAY ACUVUE® MOIST®
Active Comparator: Proclear 1 day
Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.
Device: Omafilcon A contact lenses
Other Name: Proclear® 1 day
- Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours [ Time Frame: Hour 8 ]The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.
- Total Wettability Score [ Time Frame: Hour 8 ]The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839318
|Study Director:||Jessie Lemp, PhD||Alcon Research|