Status:
COMPLETED
Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome
Lead Sponsor:
Ocuwize LTD
Conditions:
Dry Eye Due to Sjögren's Syndrome
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD.
- Active abuse of alcohol or drugs.
- Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03319420
Start Date
March 29 2018
End Date
January 1 2021
Last Update
February 25 2021
Active Locations (5)
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1
HaEmek MC
Afula, Israel
2
Rambam
Haifa, Israel
3
Rabin MC
Petah Tikva, Israel
4
Kaplan MC
Rehovot, Israel