NCT03723811
Completed
Phase 2
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.
ConditionsDry Eye Syndromes
Overview
- Phase
- Phase 2
- Intervention
- SJP002 BID
- Conditions
- Dry Eye Syndromes
- Sponsor
- Samjin Pharmaceutical Co., Ltd.
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Change from baseline of Fluorescein Corneal Staining(FCS) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is to evaluate the efficacy and safety of SJP002 ophthalmic solution compared to placebo in patients with Dry Eye Syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must meet all criteria listed below at least in one eye.
- •Fluorescein corneal staining score ≥ 2
- •Schirmer test ≤ 10mm in 5 mins
- •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.
Arms & Interventions
1
SJP002 BID
Intervention: SJP002 BID
2
SJP002 QID
Intervention: SJP002 QID
Placebo 1
SJP002 Placebo 1
Intervention: SJP002 Placebo 1
Placebo 2
SJP002 Placebo 2
Intervention: SJP002 Placebo 2
Outcomes
Primary Outcomes
Change from baseline of Fluorescein Corneal Staining(FCS) score
Time Frame: 4 weeks
The degree of corneal inflammation is scored (total of 5 points) according to the Oxford grading scale from 0 (no staining, A) to 5 (severe, confluent staining, \>E).
Secondary Outcomes
- Change from baseline of Fluorescein Corneal Staining(FCS) score(2 weeks)
- Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score(2, 4 weeks)
- Change from baseline of Schirmer Test score(2, 4 weeks)
- Change from baseline of Tear Break-Up Time(TBUT)(2, 4 weeks)
- Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)(4 weeks)
- Numbers of used artificial tears during the study period(4 weeks)
Study Sites (1)
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