Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

Last updated: August 27, 2018
Sponsor: Hanlim Pharm. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT01768312
HL_TSPR_301
  • Ages > 21
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 teareye drops, sympathetic nervous system stimulant agent, parasympathetic nervestimulant, 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 ofchildbearing age or menopause (1 year after the last menstrual period women)Sterilization (eg, bilateral oophorectomy, hysterectomy) women of childbearingage have not been effective contraception only if you participate in a clinicaltrial 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

Exclusion Criteria:

    1. Screening visits in the previous 3 months (12 weeks) who participated in theclinical trials of cyclosporine eye drops, or if you used a cyclosporine ophthalmicsolutions.
  1. The patients with systemic or ocular disorders affected the test results (ocularsurgery, 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, conjunctivalscarring (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 eyesyndrome medications (topical or systemic) that may affect the status 4) The usein clinical trials of drug hypersensitivity reactions in patients 5) patientswith 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) Theend of the lacrimal gland disease (Nasal stimulation Schirmer test value <3mm/5min) 11) History of malignancy 12) If you are receiving systemic steroidsor immunosuppressive treatment 15) In patients with severe renal failure (serumcreatinine more than 2.0 times the upper limit of normal) 16) In patients withsevere liver dysfunction (ALT or AST of more than 2.0 times the upper limit ofnormal) 17) Alcohol or drug abuse 18) Pregnant women, lactating women 19)Participating in a Clinical Trial patients who have participated in otherclinical trials within three months 20) Patients judged coexisting disease thatcould interfere with the completion of the treatment or safety of this clinicaltrial. Patients that other researchers are determined inadequately

Study Design

Total Participants: 84
Study Start date:
August 23, 2012
Estimated Completion Date:
July 31, 2013

Study 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

Connect with a study center

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

    Seoul, Seocho-Ku 137-701
    Korea, Republic of

    Site Not Available

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