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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:March 10, 2019
End Date:December 31, 2019
Contact:Joohyun Chae
Email:hpi-usa@hanall.co.kr

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A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

The objective of this study is 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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
3
sites
Louisville, Kentucky 40206
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Louisville, KY
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Andover, Massachusetts 01810
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Andover, MA
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Indianapolis, Indiana 46290
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Indianapolis, IN
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