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

• Sponsor: Samjin Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03723811
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 22

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: SJP002 BID; Drug: SJP002 QID; Drug: SJP002 Placebo 1; Drug: SJP002 Placebo 2	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Nov 28, 2017
• Actual Primary Completion Date: Jun 26, 2018
• Actual Study Completion Date: Jun 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SJP002 BID	Drug: SJP002 BID; 1 drop b.i.d for 12 weeks
Experimental: 2 SJP002 QID	Drug: SJP002 QID; 1 drop q.i.d for 12 weeks
Placebo Comparator: Placebo 1 SJP002 Placebo 1	Drug: SJP002 Placebo 1; 1 drop q.i.d for 12 weeks
Placebo Comparator: Placebo 2 SJP002 Placebo 2	Drug: SJP002 Placebo 2; 1 drop q.i.d for 12 weeks

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

3. Change from baseline of Schirmer Test score [2, 4 weeks]

   Change from Baseline, 2, 4 Weeks

4. Change from baseline of Tear Break-Up Time(TBUT) [2, 4 weeks]

   Change from Baseline, 2, 4 Weeks

5. Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) [4 weeks]

   Change from Baseline, 4 Weeks

6. Numbers of used artificial tears during the study period [4 weeks]

   Change from Baseline, 4 Weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samjin Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Choun-Ki Joo, M.D.,Ph.D., Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samjin Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03723811
• Other Study ID Numbers: SJSJP002_02
• First Posted: Oct 30, 2018
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

No Results Posted as of Apr 7, 2022