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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01706770
Other study ID # FC111216
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date October 2012

Study information

Verified date September 2020
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period.


Description:

The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
enfilcon A

galyfilcon A


Locations

Country Name City State
United States Vision Care Associates East Lansing Michigan
United States Advanced Eyecare Pismo Beach California
United States Eric M. White, OD, Inc. San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Assessment: Ocular Response - Biomicroscopy 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.
Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
Primary Comparison of Objective Findings - Number of Adverse Events in Unique Eyes 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.
Any occurrence from baseline to 1 month visit
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