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Completed

NCT Number: NCT03723811

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

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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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul St. Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

SJP002 BID

Drug

1 drop b.i.d for 12 weeks

SJP002 QID

Drug

1 drop q.i.d for 12 weeks

SJP002 Placebo 1

Drug

1 drop q.i.d for 12 weeks

SJP002 Placebo 2

Drug

1 drop q.i.d for 12 weeks

Primary outcomes

  1. Change from baseline of Fluorescein Corneal Staining(FCS) score

    Time frame: 4 weeks

    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).

Secondary outcomes

  1. Change from baseline of Fluorescein Corneal Staining(FCS) score

    Time frame: 2 weeks

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

    Time frame: 2, 4 weeks

    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).

  3. Change from baseline of Schirmer Test score

    Time frame: 2, 4 weeks

    Change from Baseline, 2, 4 Weeks

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

    Time frame: 2, 4 weeks

    Change from Baseline, 2, 4 Weeks

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

    Time frame: 4 weeks

    Change from Baseline, 4 Weeks

  6. Numbers of used artificial tears during the study period

    Time frame: 4 weeks

    Change from Baseline, 4 Weeks

Sponsors and collaborators

Lead sponsor

Samjin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2018
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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