A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT03846453

Run by

HanAll BioPharma Co., Ltd.

People needed

637

Starts

2019-03-10

Expected to finish

2019-11-22

Last updated by the study team

2022-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Eye Research Foundation — Newport Beach, California, United States
• East West Eye Institute — Torrance, California, United States
• Specialty Retina Center — Boynton Beach, Florida, United States
• Specialty Retina Center — Coral Springs, Florida, United States
• Eye Care Centers Management Inc — Morrow, Georgia, United States
• MidWest Cornea Associates, LLC — Indianapolis, Indiana, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Andover Eye Associates — Raynham, Massachusetts, United States
• Vita Eye Clinic — Shelby, North Carolina, United States
• Total Eye Care, P A — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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