Clinical Study to Investigate the Efficacy and Safety of Orally Administered SA001 in Patients With Dry Eye Syndrome.

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety of orally administered SA001 compared to placebo in patients with Dry Eye Syndrome .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samjin Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Age over 19.

• Must meet all criteria listed below at least in one eye.

1. Fluorescein corneal staining score ≥ 2

2. Schirmer test ≤ 10mm in 5 mins

3. Tear break-up time ≤ 10 secs

Exclusion Criteria:

• Ocular disorder that may confound interpretation of study results.

• Wearing contact lenses 72 hrs prior to screening visit and unwilling to avoid wearing contact lenses for the duration of the study period.

• History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to screening visit, and/or any other intraocular surgery within 90 days prior to screening visit.

• Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test.

• Participation in other studies within 30 days of screening visit.