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

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.

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: SJP002 BID; Drug: SJP002 QID; Drug: SJP002 Placebo 1; Drug: SJP002 Placebo 2

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samjin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2017
• Primary Completion (ACTUAL): June 26, 2018
• Study Completion (ACTUAL): June 26, 2018

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (ACTUAL): October 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SJSJP002_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No