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

A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye Syndrome.

This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.

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.