Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02229955

Acronym

HL_TSPR_302

Enrollment

Registered

2014-09-03

Start date

2013-12-31

Completion date

2014-07-31

Last updated

2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry Eye Syndromes

Brief summary

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

Interventions

DRUGCyclosporine ophthalmic solution

1 drop twice/day for 12 weeks to both eyes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

\[Patients with moderate-to-severe ocular dry eye\] 1. The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading) 2. Non-anesthetic Schirmer test value ≤ 10mm/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. Tear break-up time is 10 seconds or less 4. Screening both eyes, the corrected visual acuity is 0.2 or more 5. Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)

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 cyclosporin 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

Design outcomes

Primary

Measure	Time frame
Corneal staining test	12 weeks

Secondary

Measure	Time frame
Corneal staining test	4, 8 weeks
Ocular surface disease index (OSDI)	4, 8, 12 weeks
Tear break up time (TBUT)	4, 8, 12 weeks
Non-anesthetic Schirmer test	4, 8, 12 weeks
Conjunctival staining	4, 8, 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026