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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Sodium hyaluronate
Active Ingredients; Polyethylene Glycol Propylene Glycol
HaEmek MC
Afula, Israel
Rambam
Haifa, Israel
Rabin MC
Petah Tikva, Israel
Kaplan MC
Rehovot, Israel
Ichilov medical center Tel Aviv
Tel Aviv, Israel
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
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.
Time frame: 3 months form the basline
Change in Ocular Surface Disease Index (OSDI) questionnaire score.
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.
Time frame: 1 and 3 months from the basline visit
Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System
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.
Time frame: After one month
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