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 (HL_TSPR_302)

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporine ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02229955

HL_TSPR_302

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

86 participants in 2 patient groups

T-sporin eye drop

Experimental group

Description:

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

Treatment:

Drug: Cyclosporine ophthalmic solution

Restasis eye drop

Active Comparator group

Description:

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

Treatment:

Drug: Cyclosporine ophthalmic solution