CompletedPhase 4

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

Israel60 participantsStarted 2018-03-29

Plain-language 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.

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female of any race and ≥ 18 years of age. * Willing and able to provide voluntary written informed consent. * Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002). * Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening. * Willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk. * Subjects with pterygium. * Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin. * Subjects with blepharitis requiring treatment. * Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening. * Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial. * Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study. * Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1. * Known hypersensitivity to …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in corneal / conjunctival staining score using the National Eye Institute/Industry(NEI) Industry Grading System

Timeframe: 3 months form the basline

Trial details

NCT IDNCT03319420

SponsorOcuwize LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-01

View on ClinicalTrials.gov More Dry Eye Due to Sjögren's Syndrome trials