Effects of Multifocal Contact Lens on Ocular Tissue
|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: NCT02345720|
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : October 5, 2016
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Visual Acuity||Device: etafilcon - PVP (multi-focal)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: etafilcon - PVP (multi-focal)
The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.
Device: etafilcon - PVP (multi-focal)
The investigational contact lens must be worn at least six hours daily.
- Upper Eye Lid Margin Staining [ Time Frame: 30 days Post wear ]Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.
- Limbal Staining [ Time Frame: 30 Days Post Wear ]Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
- Corneal Staining [ Time Frame: 30 Days Post Wear ]The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
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): NCT02345720
|London, United Kingdom, SW1E6AU|