Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839318
|Study Director:||Jessie Lemp, PhD||Alcon Research|