Overview

Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

Status:
Completed
Trial end date:
2013-07-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Treatments:
Cyclosporine
Cyclosporins
Ophthalmic Solutions
Tetrahydrozoline
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