Status:
COMPLETED
A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Eligibility Criteria
Inclusion
- Have a patient-reported history of dry eye for at least 6 months prior to enrollment
- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
- Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2
Exclusion
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
- Have used Restasis® or Xiidra® within 60 days of Visit 1
- Be currently taking any topical ophthalmic prescription (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 (excluding medications allowed for the conduct of the study)
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
Key Trial Info
Start Date :
November 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03334539
Start Date
November 5 2017
End Date
April 9 2018
Last Update
March 7 2024
Active Locations (2)
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1
Central Maine Eye Care
Lewiston, Maine, United States, 04240
2
Andover Eye Associates
Andover, Massachusetts, United States, 01810