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

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: SJP002 BID; Drug: SJP002 QID; Drug: SJP002 Placebo 1; Drug: SJP002 Placebo 2

• Registration Number: NCT03723811
• Lead Sponsor: Samjin Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Primary Completion: 2018-06-26
• Study Completion: 2018-06-26
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SJP002 BID	SJP002 BID
2	SJP002 QID	SJP002 QID
Placebo 1	SJP002 Placebo 1	SJP002 Placebo 1
Placebo 2	SJP002 Placebo 2	SJP002 Placebo 2

Primary Outcome Measures

Name	Time	Method
Change from baseline of Fluorescein Corneal Staining(FCS) score	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 Outcome Measures

Name	Time	Method
Change from baseline of Fluorescein Corneal Staining(FCS) score	2 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).
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score	2, 4 weeks	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).
Change from baseline of Schirmer Test score	2, 4 weeks	Change from Baseline, 2, 4 Weeks
Change from baseline of Tear Break-Up Time(TBUT)	2, 4 weeks	Change from Baseline, 2, 4 Weeks
Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)	4 weeks	Change from Baseline, 4 Weeks
Numbers of used artificial tears during the study period	4 weeks	Change from Baseline, 4 Weeks

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of