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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SJP002 BID
SJP002 QID
SJP002 Placebo 1
SJP002 Placebo 2
Sponsored by
Samjin Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

Placebo 1

Placebo 2

Arm Description

SJP002 BID

SJP002 QID

SJP002 Placebo 1

SJP002 Placebo 2

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
Change from baseline of Schirmer Test score
Change from Baseline, 2, 4 Weeks
Change from baseline of Tear Break-Up Time(TBUT)
Change from Baseline, 2, 4 Weeks
Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)
Change from Baseline, 4 Weeks
Numbers of used artificial tears during the study period
Change from Baseline, 4 Weeks

Full Information

First Posted
October 26, 2018
Last Updated
March 30, 2022
Sponsor
Samjin Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03723811
Brief Title
Clinical Study to Investigate the Efficacy and Safety of SJP002 Ophthalmic Solution in Patients With Dry Eye Syndrome.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samjin Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SJP002 BID
Arm Title
2
Arm Type
Experimental
Arm Description
SJP002 QID
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Description
SJP002 Placebo 1
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Arm Description
SJP002 Placebo 2
Intervention Type
Drug
Intervention Name(s)
SJP002 BID
Intervention Description
1 drop b.i.d for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SJP002 QID
Intervention Description
1 drop q.i.d for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SJP002 Placebo 1
Intervention Description
1 drop q.i.d for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SJP002 Placebo 2
Intervention Description
1 drop q.i.d for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline of Fluorescein Corneal Staining(FCS) score
Description
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 Outcome Measure Information:
Title
Change from baseline of Fluorescein Corneal Staining(FCS) score
Description
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
Title
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
Description
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
Title
Change from baseline of Schirmer Test score
Description
Change from Baseline, 2, 4 Weeks
Time Frame
2, 4 weeks
Title
Change from baseline of Tear Break-Up Time(TBUT)
Description
Change from Baseline, 2, 4 Weeks
Time Frame
2, 4 weeks
Title
Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)
Description
Change from Baseline, 4 Weeks
Time Frame
4 weeks
Title
Numbers of used artificial tears during the study period
Description
Change from Baseline, 4 Weeks
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choun-Ki Joo, M.D.,Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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