Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
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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 |
- Corneal staining test [ Time Frame: Administered 12 weeks after ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
[Patients with moderate-to-severe ocular dry eye]
- The sum of corneal fluorescein staining score of 5 or higher (NEI Scale)
- 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)
- Screening both eyes, the corrected visual acuity is 0.2 or more
- Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
- Negative urine pregnancy test at the screening when women of childbearing age
- 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.
- 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)
- Abnormal eyelid function : Disoders of the eyelids or eyelashes
- Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
- 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| Contact: Eun Mi Kim, Bachelor | (822)3489-6162 | emkim@hanlim.com |
| 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 | |
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:
|
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Tetrahydrozoline Cyclosporins Cyclosporine Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013