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 |
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.
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
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