Performance of a Multifocal Contact Lens - Presbyopia Study
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|ClinicalTrials.gov Identifier: NCT02450747|
Recruitment Status : Completed
First Posted : May 21, 2015
Results First Posted : January 12, 2017
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Device: etafilcon A MULTIFOCAL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Multifocal Test Contact Lens
Subjects will wear the etafilcon A Multifocal test lens in a daily wear modality.
Device: etafilcon A MULTIFOCAL
Subjects will wear the test lens for four weeks.
- The Total Grade of Conjunctival Hyperemia [ Time Frame: Baseline to 4-Week Follow-up ]Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
- Upper Lid Margin Staining Score [ Time Frame: Baseline to 4-Week Follow-up ]Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.
- Average Corneal Staining Area Grade [ Time Frame: Baseline to 4- Week Follow-up ]Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and 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): NCT02450747
|Waterloo, Ontario, Canada, N2L 3G1|