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

Dry Eye Syndromes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723811
• Other study ID #: SJSJP002_02
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2017
• Est. completion date: June 26, 2018

Study information

• Verified date: March 2022
• Source: Samjin Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• SJP002 BID
1 drop b.i.d for 12 weeks
• SJP002 QID
1 drop q.i.d for 12 weeks
• SJP002 Placebo 1
1 drop q.i.d for 12 weeks
• SJP002 Placebo 2
1 drop q.i.d for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samjin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline of Schirmer Test score	Change from Baseline, 2, 4 Weeks	2, 4 weeks
Secondary	Change from baseline of Tear Break-Up Time(TBUT)	Change from Baseline, 2, 4 Weeks	2, 4 weeks
Secondary	Change from baseline of Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)	Change from Baseline, 4 Weeks	4 weeks
Secondary	Numbers of used artificial tears during the study period	Change from Baseline, 4 Weeks	4 weeks