Overview

Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samjin Pharmaceutical Co., Ltd.
Treatments:
Ophthalmic Solutions
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.