Clinical trial NCT01768312: Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 84
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Corneal staining test
timeFrame: Administered 12 weeks after
Secondary outcomes:
measure: Tear break up time (TBUT)
timeFrame: Administered 4, 8, 12 weeks after
measure: Corneal staining test
timeFrame: Administered 4, 8 weeks after
measure: Ocular surface disease index (OSDI)
timeFrame: Administered 4, 8, 12 weeks after
measure: Non-anesthetic Schirmer test
timeFrame: Administered 4, 8, 12 weeks after
measure: Conjunctival staining
timeFrame: Administered 4, 8, 12 weeks after
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The catholic university of Korea seoul st. Mary's hospital
state: Seocho-Ku
Study officials:
References: