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Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group (Cyclosporine)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Hanlim Pharm. Co., Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd. Identifier:
First received: December 10, 2012
Last updated: January 11, 2013
Last verified: January 2013

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 Intervention Phase
Dry Eye Syndromes
Drug: Cyclosporine ophthalmic solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Hanlim Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Corneal staining test [ Time Frame: Administered 12 weeks after ]

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

Estimated Enrollment: 86
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


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

Inclusion Criteria:

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

    1. The sum of corneal fluorescein staining score of 5 or higher (NEI Scale)
    2. Non-anesthetic Schirmer test value ≤ 5mm/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. Screening both eyes, the corrected visual acuity is 0.2 or more
    4. Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
    5. Negative urine pregnancy test at the screening when women of childbearing age
    6. Medically reliable method of contraception in the case of all women of childbearing age or menopause (1 year after the last menstrual period women) Sterilization (eg, bilateral oophorectomy, hysterectomy) women of childbearing age have not been effective contraception only if you participate in a clinical trial may have been determined to be pregnant by examining whether the voice, maintained during the entire clinical trial period shall that.
    7. Written consent voluntarily to participate in this clinical trial

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 cyclosporine 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 5) patients with contact lens 6) If you use or plan to use punctual plug within 4 weeks 7) Lacrimal punctual occlusion surgery patients 8) Ocular surgery within 3 months (12 weeks) 9) Pregnant women, lactating, or planning to become pregnant 10) The end of the lacrimal gland disease (Nasal stimulation Schirmer test value <3mm/5min) 11) History of malignancy 12) If you are receiving systemic steroids or immunosuppressive treatment 15) In patients with severe renal failure (serum creatinine more than 2.0 times the upper limit of normal) 16) In patients with severe liver dysfunction (ALT or AST of more than 2.0 times the upper limit of normal) 17) Alcohol or drug abuse 18) Pregnant women, lactating women 19) Participating in a Clinical Trial patients who have participated in other clinical trials within three months 20) Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately
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Please refer to this study by its identifier: NCT01768312

Contact: Eun Mi Kim, Bachelor (822)3489-6162

Korea, Republic of
The catholic university of Korea seoul st. Mary's hospital Recruiting
Seoul, Seocho-Ku, Korea, Republic of, 137-701
Contact: Kyu Yeon Hwang, master    (822)2258-1188   
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

Responsible Party: Hanlim Pharm. Co., Ltd. Identifier: NCT01768312     History of Changes
Other Study ID Numbers: HL_TSPR_301
Study First Received: December 10, 2012
Last Updated: January 11, 2013

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
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
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on May 23, 2017