Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01706770|
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : April 29, 2014
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ametropia||Device: enfilcon A Device: galyfilcon A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||October 2012|
Experimental: enfilcon A
The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Device: enfilcon A
Other Name: Avaira® Toric
Active Comparator: galyfilcon A
The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Device: galyfilcon A
Other Name: Acvuve® Advance®
- Objective Assessment: Ocular Response - Biomicroscopy [ Time Frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits ]
The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
- Comparison of Objective Findings - Number of Adverse Events in Unique Eyes [ Time Frame: Any occurrence from baseline to 1 month visit ]
The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit.
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): NCT01706770
|United States, California|
|Pismo Beach, California, United States, 93449|
|Eric M. White, OD, Inc.|
|San Diego, California, United States, 48823|
|United States, Michigan|
|Vision Care Associates|
|East Lansing, Michigan, United States, 48823|
|Principal Investigator:||Scott E Schachter, OD||Unafiliated|
|Principal Investigator:||Cheryl Vincent-Reimer, OD||Unafiliated|
|Principal Investigator:||Eric White, OD||Unafiliated|