Status:
COMPLETED
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study was to compare the safety and efficacy of 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 Visit 1
- Be willing and able to comply with all study procedures
- Have 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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
- Have any previous experience using HL036
Key Trial Info
Start Date :
March 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2019
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT03846453
Start Date
March 10 2019
End Date
November 22 2019
Last Update
April 14 2022
Active Locations (12)
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1
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
East West Eye Institute
Torrance, California, United States, 90505
4
Specialty Retina Center
Boynton Beach, Florida, United States, 33437