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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03723811
Enrollment
152
Registered
2018-10-30
Start date
2017-11-28
Completion date
2018-06-26
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Brief summary

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

Interventions

DRUGSJP002 BID

1 drop b.i.d for 12 weeks

DRUGSJP002 QID

1 drop q.i.d for 12 weeks

DRUGSJP002 Placebo 1

1 drop q.i.d for 12 weeks

DRUGSJP002 Placebo 2

1 drop q.i.d for 12 weeks

Sponsors

Samjin Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of Fluorescein Corneal Staining(FCS) score4 weeksThe 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

MeasureTime frameDescription
Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score2, 4 weeksImmediately 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 score2, 4 weeksChange from Baseline, 2, 4 Weeks
Change from baseline of Fluorescein Corneal Staining(FCS) score2 weeksThe 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 Standard Patient Evaluation of Eye Dryness questionnaire(SPEED)4 weeksChange from Baseline, 4 Weeks
Numbers of used artificial tears during the study period4 weeksChange from Baseline, 4 Weeks
Change from baseline of Tear Break-Up Time(TBUT)2, 4 weeksChange from Baseline, 2, 4 Weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026