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

NCT03723811 | Completed Phase 2

• 1 other identifier: SJSJP002_02
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline of Fluorescein Corneal Staining(FCS) score

  2 weeks

• Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score

  2, 4 weeks

• Change from baseline of Schirmer Test score

  2, 4 weeks

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

  2, 4 weeks

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

  4 weeks

Study Arms (4)

1

EXPERIMENTAL

SJP002 BID

Drug: SJP002 BID

2

EXPERIMENTAL

SJP002 QID

Drug: SJP002 QID

Placebo 1

PLACEBO COMPARATOR

SJP002 Placebo 1

Drug: SJP002 Placebo 1

Placebo 2

PLACEBO COMPARATOR

SJP002 Placebo 2

Drug: SJP002 Placebo 2

Interventions

SJP002 BID DRUG

1 drop b.i.d for 12 weeks

1

SJP002 QID DRUG

1 drop q.i.d for 12 weeks

2

SJP002 Placebo 1 DRUG

1 drop q.i.d for 12 weeks

Placebo 1

SJP002 Placebo 2 DRUG

1 drop q.i.d for 12 weeks

Placebo 2

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Choun-Ki Joo, M.D.,Ph.D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: November 28, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)