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

Samjin Pharmaceutical Co., Ltd.152 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Dry Eye Syndromes

Interventions

SJP002 BIDDRUG

1 drop b.i.d for 12 weeks

SJP002 QIDDRUG

1 drop q.i.d for 12 weeks

SJP002 Placebo 1DRUG

1 drop q.i.d for 12 weeks

SJP002 Placebo 2

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul St. Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 4 weeks

Secondary Outcomes

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).

Time frame: 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).

Time frame: 2, 4 weeks

Change from baseline of Schirmer Test score

Change from Baseline, 2, 4 Weeks

Time frame: 2, 4 weeks

Change from baseline of Tear Break-Up Time(TBUT)

Change from Baseline, 2, 4 Weeks

Time frame: 2, 4 weeks

Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)

Change from Baseline, 4 Weeks

Time frame: 4 weeks

Numbers of used artificial tears during the study period

Change from Baseline, 4 Weeks

Time frame: 4 weeks

Data from ClinicalTrials.gov

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