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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-06-26

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

SJP002 BID

Group Type EXPERIMENTAL

SJP002 BID

Intervention Type DRUG

1 drop b.i.d for 12 weeks

2

SJP002 QID

Group Type EXPERIMENTAL

SJP002 QID

Intervention Type DRUG

1 drop q.i.d for 12 weeks

Placebo 1

SJP002 Placebo 1

Group Type PLACEBO_COMPARATOR

SJP002 Placebo 1

Intervention Type DRUG

1 drop q.i.d for 12 weeks

Placebo 2

SJP002 Placebo 2

Group Type PLACEBO_COMPARATOR

SJP002 Placebo 2

Intervention Type DRUG

1 drop q.i.d for 12 weeks

Interventions

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SJP002 BID

1 drop b.i.d for 12 weeks

Intervention Type DRUG

SJP002 QID

1 drop q.i.d for 12 weeks

Intervention Type DRUG

SJP002 Placebo 1

1 drop q.i.d for 12 weeks

Intervention Type DRUG

SJP002 Placebo 2

1 drop q.i.d for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No