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

Last updated: September 2, 2014
Sponsor: Hanlim Pharm. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eyes

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT02229955
HL_TSPR_302
  • Ages > 21
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 eyedrops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant,etc.)

Exclusion

Exclusion Criteria:

  1. Screening visits in the previous 3 months (12 weeks) who participated in the clinicaltrials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.

  2. The patients with systemic or ocular disorders affected the test results (ocularsurgery, trauma, or disease)

  3. Abnormal eyelid function : Disoders of the eyelids or eyelashes

  4. Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)

  5. Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctivalscarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid),pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis,keratoconus, corneal transplantation

  6. current or recent patients used dry eye syndrome medications (topical or systemic)that may affect the status

  7. The use in clinical trials of drug hypersensitivity reactions in patients

Study Design

Total Participants: 86
Study Start date:
December 01, 2013
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • The catholic university of Korea seoul st. Mary's hospital

    Seoul, Seocho-Ku 137-701
    Korea, Republic of

    Site Not Available

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