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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT03334539

Run by

HanAll BioPharma Co., Ltd.

People needed

150

Starts

2017-11-05

Expected to finish

2018-04-09

Last updated by the study team

2024-03-07

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 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

You may not qualify if…

• 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

Where it is running

• Central Maine Eye Care — Lewiston, Maine, United States
• Andover Eye Associates — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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