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.
The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Advanced Eyecare
Pismo Beach, California, United States
Eric M. White, OD, Inc.
San Diego, California, United States
Vision Care Associates
East Lansing, Michigan, United States
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.
Time frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits
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.
Time frame: Any occurrence from baseline to 1 month visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.