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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)

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ClinicalTrials.gov Identifier: NCT02229955
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Brief 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


Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Cyclosporine ophthalmic solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: T-sporin eye drop
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
Drug: Cyclosporine ophthalmic solution
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
Drug: Cyclosporine ophthalmic solution
1 drop twice/day for 12 weeks to both eyes
Other Names:
  • Restasis Eye Drops
  • Tisporin Eye Drops




Primary Outcome Measures :
  1. Corneal staining test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Corneal staining test [ Time Frame: 4, 8 weeks ]
  2. Ocular surface disease index (OSDI) [ Time Frame: 4, 8, 12 weeks ]
  3. Tear break up time (TBUT) [ Time Frame: 4, 8, 12 weeks ]
  4. Non-anesthetic Schirmer test [ Time Frame: 4, 8, 12 weeks ]
  5. Conjunctival staining [ Time Frame: 4, 8, 12 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229955


Locations
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Korea, Republic of
The catholic university of Korea seoul st. Mary's hospital
Seoul, Seocho-Ku, Korea, Republic of, 137-701
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.

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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02229955     History of Changes
Other Study ID Numbers: HL_TSPR_302
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014
Keywords provided by Hanlim Pharm. Co., Ltd.:
Dry Eye Syndromes
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Ophthalmic Solutions
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Pharmaceutical Solutions