Trial record 11 of 84 for:    Open Studies | "Lacrimal Apparatus Diseases"

Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hanlim Pharm. Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01768312
First received: December 10, 2012
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal staining test [ Time Frame: Administered 4, 8 weeks after ] [ Designated as safety issue: No ]
  • Ocular surface disease index (OSDI) [ Time Frame: Administered 4, 8, 12 weeks after ] [ Designated as safety issue: No ]
  • Tear break up time (TBUT) [ Time Frame: Administered 4, 8, 12 weeks after ] [ Designated as safety issue: No ]
  • Non-anesthetic Schirmer test [ Time Frame: Administered 4, 8, 12 weeks after ] [ Designated as safety issue: No ]
  • Conjunctival staining [ Time Frame: Administered 4, 8, 12 weeks after ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768312

Contacts
Contact: Eun Mi Kim, Bachelor (822)3489-6162 emkim@hanlim.com

Locations
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    yeon424@paran.com   
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
  More Information

No publications provided

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01768312     History of Changes
Other Study ID Numbers: HL_TSPR_301
Study First Received: December 10, 2012
Last Updated: January 11, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Cyclosporine
Cyclosporins
Ophthalmic Solutions
Tetrahydrozoline
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Autonomic Agents
Cardiovascular Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics

ClinicalTrials.gov processed this record on October 29, 2014