Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group (Cyclosporine)

• ClinicalTrials.gov Identifier: NCT01768312
• Recruitment Status: Completed
• First Posted: January 15, 2013
• Last Update Posted: August 29, 2018
• Sponsor: Hanlim Pharm. Co., Ltd.
• Information provided by (Responsible Party): Hanlim Pharm. Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndromes	Drug: Cyclosporine ophthalmic solution	Phase 3

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 23, 2012
• Actual Primary Completion Date: July 31, 2013
• Actual Study Completion Date: July 31, 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Restasis eye drop; Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes	Drug: Cyclosporine ophthalmic solution; 1 drop twice/day for 12 weeks to both eyes; Other Names: Restasis Eye Drops; Tisporin Eye Drops
Experimental: T-sporin eye drop; Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes	Drug: Cyclosporine ophthalmic solution; 1 drop twice/day for 12 weeks to both eyes; Other Names: Restasis Eye Drops; Tisporin Eye Drops

Outcome Measures

Primary Outcome Measures :

1. Corneal staining test [ Time Frame: Administered 12 weeks after ]
   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

Secondary Outcome Measures :

1. Tear break up time (TBUT) [ Time Frame: Administered 4, 8, 12 weeks after ]
   After blinking blue fluorescein staining of the cobalt blue light source using a yellow filter, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.
2. Corneal staining test [ Time Frame: Administered 4, 8 weeks after ]
   Corneal staining was performed at each visit. 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
3. Ocular surface disease index (OSDI) [ Time Frame: Administered 4, 8, 12 weeks after ]
   The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.
4. Non-anesthetic Schirmer test [ Time Frame: Administered 4, 8, 12 weeks after ]
   After the eyes were examined, the eyes were wiped and the Schirmer test paper was inserted into the right eye at 1/3 of the lower eyelid without eye anesthesia and inserted into the left eye. After 5 minutes with the eyes closed, the Schirmer test paper was removed from the right side in the order of insertion and the left side removed. The wet length was measured in millimeters and the length of the midpoint was measured when the wet border was oblique.
5. Conjunctival staining [ Time Frame: Administered 4, 8, 12 weeks after ]
   After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

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

Seoul, Seocho-Ku, Korea, Republic of, 137-701

Sponsors and Collaborators

Hanlim Pharm. Co., Ltd.

More Information

• Responsible Party: Hanlim Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01768312
• Other Study ID Numbers: HL_TSPR_301
• First Posted: January 15, 2013
• Last Update Posted: August 29, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Cyclosporine; Ophthalmic Solutions; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Pharmaceutical Solutions