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

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

Official Title
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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.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: SJP002 BID
* Drug: SJP002 QID
* Drug: SJP002 Placebo 1
* Drug: SJP002 Placebo 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 19. 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SJP002 BID | Drug: SJP002 BID<br>* 1 drop b.i.d for 12 weeks<br>|
| Experimental: 2<br>SJP002 QID | Drug: SJP002 QID<br>* 1 drop q.i.d for 12 weeks<br>|
| Placebo Comparator: Placebo 1<br>SJP002 Placebo 1 | Drug: SJP002 Placebo 1<br>* 1 drop q.i.d for 12 weeks<br>|
| Placebo Comparator: Placebo 2<br>SJP002 Placebo 2 | Drug: SJP002 Placebo 2<br>* 1 drop q.i.d for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Fluorescein Corneal Staining(FCS) score | 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Fluorescein Corneal Staining(FCS) score | 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). | 2 weeks | 
| Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score | Immediately after dyeing (max within 2 minutes), Scored by using slit lamp on white light and a red barrier filte according to the Oxford scheme using a source From 0 (no staining, A) up to 5 (severe, confluent staining, >E) (10 points in total). | 2, 4 weeks | 
| Change from baseline of Schirmer Test score | Change from Baseline, 2, 4 Weeks | 2, 4 weeks | 
| Change from baseline of Tear Break-Up Time(TBUT) | Change from Baseline, 2, 4 Weeks | 2, 4 weeks | 
| Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) | Change from Baseline, 4 Weeks | 4 weeks | 
| Numbers of used artificial tears during the study period | Change from Baseline, 4 Weeks | 4 weeks |