The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
230
Ophthalmic Solution
Ophthalmic Solution
The Eye Care Group
Waterbury, Connecticut, United States
Central Maine Eye Care
Lewiston, Maine, United States
Ora, Inc. (two locations)
Andover, Massachusetts, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Time frame: Day 84
Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Time frame: Baseline (Day 0) and Day 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Eye Care, P.A.
Memphis, Tennessee, United States