NCT03319420

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

A Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ocuwize LTD · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-masked, comparative study versus Systane ultra UD, to evaluate the efficacy and safety of LO2A eye drops for symptomatic improvement of dry eye in Patients with Sjögren's syndrome. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or Systane ultra UD, respectively. The study will consist of a screening period of up to two weeks and a 3-month double blind treatment period (topical application of eye drops four times daily) Up to 60 subjects are planned to be recruited to this study, randomized to one of two treatment arms using a 1:1 active (LO2A) to Systane ultra UD ratio.

Conditions

• Dry Eye Due to Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	LO2A eye drops	Sodium hyaluronate
DRUG	Systane Ultra UD	Active Ingredients; Polyethylene Glycol Propylene Glycol

Timeline

• Start date: 2018-03-29
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2017-10-24
• Last updated: 2021-02-25

Locations

5 sites across 1 country: Israel