Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-10 @ 5:55 PM
Study NCT ID:
NCT03319420
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2017-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Sponsor:
Ocuwize LTD
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: