Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

NCT01768312 | Completed Phase 3

• 1 other identifier: HL_TSPR_301
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Corneal staining test

  The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system

  Administered 12 weeks after

Secondary Outcomes (5)

• Tear break up time (TBUT)

  Administered 4, 8, 12 weeks after

• Corneal staining test

  Administered 4, 8 weeks after

• Ocular surface disease index (OSDI)

  Administered 4, 8, 12 weeks after

• Non-anesthetic Schirmer test

  Administered 4, 8, 12 weeks after

• Conjunctival staining

  Administered 4, 8, 12 weeks after

Study Arms (2)

Restasis eye drop

ACTIVE COMPARATOR

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

Drug: Cyclosporine ophthalmic solution

T-sporin eye drop

EXPERIMENTAL

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

Drug: Cyclosporine ophthalmic solution

Interventions

Cyclosporine ophthalmic solution DRUG

1 drop twice/day for 12 weeks to both eyes

Also known as: Restasis Eye Drops, Tisporin Eye Drops

Restasis eye drop; T-sporin eye drop

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Patients with moderate-to-severe ocular dry eye\]
• 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

You may not qualify if:

• \) 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.
• \) 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

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

Seoul, Seocho-Ku, 137-701, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: January 15, 2013
• Study Start: August 23, 2012
• Primary Completion: July 31, 2013
• Study Completion: July 31, 2013
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

KR (1)