Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease (HL_TSPR_302)

September 2, 2014 updated by: Hanlim Pharm. Co., Ltd.

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease

The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) 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.

- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Seocho-Ku
      • Seoul, Seocho-Ku, Korea, Republic of, 137-701
        • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

[Patients with moderate-to-severe ocular dry eye]

  1. The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
  2. Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value ≥ 3mm/5min)
  3. Tear break-up time is 10 seconds or less
  4. Screening both eyes, the corrected visual acuity is 0.2 or more
  5. Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)

Exclusion Criteria:

  1. Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
  2. The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)

    1. Abnormal eyelid function : Disoders of the eyelids or eyelashes
    2. Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
    3. Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation
  3. current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
  4. The use in clinical trials of drug hypersensitivity reactions in patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T-sporin eye drop
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
1 drop twice/day for 12 weeks to both eyes
Other Names:
  • Restasis Eye Drops
  • Tisporin Eye Drops
Active Comparator: Restasis eye drop
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
1 drop twice/day for 12 weeks to both eyes
Other Names:
  • Restasis Eye Drops
  • Tisporin Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal staining test
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal staining test
Time Frame: 4, 8 weeks
4, 8 weeks
Ocular surface disease index (OSDI)
Time Frame: 4, 8, 12 weeks
4, 8, 12 weeks
Tear break up time (TBUT)
Time Frame: 4, 8, 12 weeks
4, 8, 12 weeks
Non-anesthetic Schirmer test
Time Frame: 4, 8, 12 weeks
4, 8, 12 weeks
Conjunctival staining
Time Frame: 4, 8, 12 weeks
4, 8, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 2, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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