In subjects with Dry Eye Syndrome (DES): The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES). Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Bilateral ocular drug administration
Bilateral ocular drug administration
Central Maine Eye Care
Lewiston, Maine, United States
Andover Eye Associates
Andover, Massachusetts, United States
Suite 305, 775 Paramount Drive
Raynham, Massachusetts, United States
Total Eye Care
Memphis, Tennessee, United States
Ocular grittiness 6-point (0-5) scale
Ocular grittiness severity assessment
Time frame: Day 29
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
Time frame: Day 29
Ocular discomfort 5-point (0-4) scale
Ocular discomfort severity assessment
Time frame: Day 29
Ocular dryness 6-point (0-5) scale
Ocular dryness severity assessment
Time frame: Day 29
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
Time frame: Day 29
Corneal lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
Time frame: Day 29
Worst ocular symptom 6-point (0-5) scale
Most severe baseline symptom from reported daily symptoms
Time frame: Day 29
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