Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
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|ClinicalTrials.gov Identifier: NCT03319420|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Due to Sjögren's Syndrome||Drug: LO2A eye drops Drug: Systane Ultra UD||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-Masked, comparative study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Investigator staff involved in the dispensation of study treatments and treatment compliance checks will not be involved in data collection - doublemasked treatment design.|
|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|
|Actual Study Start Date :||March 29, 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
1 drop of sodium hyaluronate instilled into each eye 4 times daily
Drug: LO2A eye drops
Active Comparator: Systane Ultra UD
1 drop of Systane Ultra UD instilled into each eye 4 times daily
Drug: Systane Ultra UD
Active Ingredients; Polyethylene Glycol Propylene Glycol
- Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [ Time Frame: 3 months form the basline ]NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.
- Change in Ocular Surface Disease Index (OSDI) questionnaire score. [ Time Frame: 1 and 3 months from the basline visit ]The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
- Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System [ Time Frame: After one month ]NEI/Industry Workshop Conjunctival Staining Grading System. Devitalized epithelial cells of the bulbar conjunctiva are stained with lissamine green and can graded across six zones The scores for each zone (0-3) are summed to obtain an overall score for each eye (0-18.( The higher the results, the more severe the dryness of the eye.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319420
|Contact: Sergiu Socea, MD||972 (4) email@example.com|
|Contact: Meital Abecasis||972 (4) firstname.lastname@example.org|
|Contact: Sergeu Socae, M.D email@example.com|
|Contact: Meital firstname.lastname@example.org|
|Ichilov medical center Tel Aviv||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Zohar Villner, MD 972-36974165 email@example.com|