A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline. This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Rambam
Haifa, Israel
Hadassah
Jerusalem, Israel
Ichilov Tel Aviv hospital
Tel Aviv, Israel
The change from baseline in lissamine green conjunctival staining (LGCS) score.
Time frame: 3 Months
The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline
Time frame: 3 Months
The change from baseline in LGCS score
Time frame: 1 month
The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months
Time frame: 3 Months
The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months
Time frame: 3 Months
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