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

Samjin Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: SJP002 Placebo 1; Drug: SJP002 QID; Drug: SJP002 Placebo 2; Drug: SJP002 BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03723811

SJSJP002_02

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

SJP002 BID

Treatment:

Drug: SJP002 BID

2

Experimental group

Description:

SJP002 QID

Treatment:

Drug: SJP002 QID

Placebo 1

Placebo Comparator group

Description:

SJP002 Placebo 1

Treatment:

Drug: SJP002 Placebo 1

Placebo 2

Placebo Comparator group

Description:

SJP002 Placebo 2

Treatment:

Drug: SJP002 Placebo 2