drugset / Trial / NCT03319420

Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

NCT03319420

Phase 4 Completed 60 enrolled Ocuwize LTD
RandomizedParallel-groupTriple-blindTreatment

Summary

Dry eye complaints occur in 5.5 to 33.7% of the population, and are ranked as the most frequent symptoms of patients visiting ophthalmologists. Dry eye syndrome is caused by the reduced production and/or improper quality of the tear film. One of the causes of reduced tear production is Sjögren's syndrome. Sjögren's is estimated to affect up to 4 million patients in the US alone. It affects mostly middle aged women (40-50 years of age) with a female to male prevalence ratio of 9:1. The current study seeks to evaluate the safety and efficacy of LO2A ophthalmic solution in the symptomatic treatment of dry eye in patients with Sjögren's syndrome. This study will be conducted in compliance with the protocol, GCP,and applicable regulatory requirements.

Timeline

Start
2018-03-29
Primary completion
2021-01-01
Completion
2021-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propylene Glycol Small molecule Topical
Subject Sodium Hyaluronate Other / unclassified Topical
Comparator polyethylene glycol Other / unclassified Topical

Indications