Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

NCT ID: NCT01768312

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-23
• Study Completion Date: 2013-07-31

Brief Summary

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

Detailed Description

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

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Restasis eye drop

Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes

Group Type: ACTIVE_COMPARATOR

Cyclosporine ophthalmic solution

Intervention Type: DRUG

1 drop twice/day for 12 weeks to both eyes

T-sporin eye drop

Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes

Group Type: EXPERIMENTAL

Cyclosporine ophthalmic solution

Intervention Type: DRUG

1 drop twice/day for 12 weeks to both eyes

Interventions

Cyclosporine ophthalmic solution

1 drop twice/day for 12 weeks to both eyes

Intervention Type: DRUG

Other Intervention Names

Restasis Eye Drops; Tisporin Eye Drops

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, Seocho-Ku, South Korea

Countries

South Korea

Other Identifiers

HL_TSPR_301

Identifier Type: -

Identifier Source: org_study_id