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Completed

NCT Number: NCT02461719

Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Catholic University of Korea 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

  • Male or female, age 20 or over
  • Patients with moderate to severe dry eye
  • Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion criteria

  • Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
  • Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
  • Intraocular pressure(IOP)> 25 mmHg
  • Patient using or to use punctual plug within 1 months.
  • Patients with contact lens.

Treatment and study plan

CYPORIN N EYE DROPS 0.05%(TJCS eye drop)

Drug

1 drop twice/day for 12 weeks to both eyes.

Other names: Cyclosporine Eye Drops(CYPORIN N)

Restasis

Drug

1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.

Other names: Cyclosporine Eye Drops (Restasis)

Primary outcomes

  1. Corneal staining test

    Time frame: 12 weeks

Secondary outcomes

  1. Corneal staining test

    Time frame: 4, 8 weeks

  2. Conjunctival staining

    Time frame: 4, 8, 12 weeks

  3. Corneal and Conjunctival staining sum Score

    Time frame: 4, 8, 12 weeks

  4. Ocular surface disease index (OSDI)

    Time frame: 4, 8, 12 weeks

  5. Tear break up time (TBUT)

    Time frame: 4, 8, 12 weeks

  6. Non-anesthetic Schirmer test

    Time frame: 4, 8, 12 weeks

  7. Frequency of concurrent drug use

    Time frame: 4, 8, 12 weeks

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Multicenter, Randomized, Double-blind phⅢ Study of TJCS Eye Drops Group and Restasis Eye Drops Group for 12 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

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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