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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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26 August 2019 |
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Main ID: |
KCT0001796 |
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Date of registration:
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2016-02-02 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical efficacy and safety of sodium hyaluronates in different concentration and cyclosporine 0.05% in patients with dry eye
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Scientific title:
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A randomized, multicenter clinical study to evaluate the efficacy and safety of sodium Hyaluronate according to multi-concentration in dry eye syndrome. |
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Date of first enrolment:
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2014-07-23 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14628 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
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Phase:
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Phase4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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HYUNSEUNG
KIM |
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Address:
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10, 63-ro, Yeongdeungpo-gu, Seoul, Korea
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Telephone:
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+82-2-3779-1848 |
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Email:
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sergio6365@gmail.com |
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Affiliation:
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The Catholic University of Korea, Yeouido St. Mary's Hospital |
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Name:
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HYUNSEUNG
KIM |
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Address:
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10, 63-ro, Yeongdeungpo-gu, Seoul, Korea
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Telephone:
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+82-2-3779-1848 |
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Email:
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sergio6365@gmail.com |
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Affiliation:
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The Catholic University of Korea, Yeouido St. Mary's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) =19 years of age
2) Dry eye symdrome lasting at least 3 months
3) = 10mm in Schirmer's I test or = 5sec on BUT
4) NEI scale = 4
5) negative on pregnancy test if of childbearing potential
6) Menopause or agreed to use a reliable from of Contaception if of childbearing potential
7) volentary agreement with signed informed consent
Exclusion criteria: 1) Current or histroy of systemic or ocular disorders possibly affecting the study results(ocular surgery, traum, or diseases)
(1) abnormal eyelid function: disorders of the eyelids or eyelashes
(2) ocular allergy history within 1 month or under treatment (topical ocular mast cell stabilizers, antihistamine etc.)
(3) herpetic keratopathy, conjunctival scarring by cicatricial keratoconjuntivitis(alkali damage, Stevens-Johnson Syndrome, cicatricial pemphigoid), pterygium, congenital lacrimal gland shortage, neurogenic keratitis, keratoconus, corneal transplantation
2) under or recent history of dry eye syndrome medications(topical or systemic) besides artificial tears(including diquafosol)
3) use of artificial tears(including diquafosol) within 1 week
4) Intraocular pressure(IOP) > 25mmHg
5) hypersensitivity to investigational drugs
6) surgery of punctual plug or lacrimal punctual occlusion within 4 weeks
7) ocular surgery within 8 weeks
8) pregnancy or breast-feeding or under childbearing plan
9) history of malignant tumor (those under treatment or history of anti-cancer therapy within 6 months)
10) under systemic steroids or immunosuppressants
11) renal dysfunction ( = 2 times of upper limit of normal serum creatinine)
12) hepatic dysfunction (= 2 times of upper limit of normal ALT or AST)
13) history of drug abuse including alcohol
14) participants in other clinical trial within the last month
15) investigator's judge of inappropiation
Age minimum:
19(Year)
Age maximum:
No Limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the eye and adnexa
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Intervention(s)
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Drug : 4 arms (3 sodium hyaluronate treatment groups with each different concentration + 1 cyclosporin treatment group)
-. HYALUNI ophthalmic solution 0.1% (sodium hyaluronate 0.1%), 1 drop/time, 5~6 times/day by symptom severity
-. NEWHYALUNI ophthalmic solution 0.15% (sodium hyaluronate 0.15%), 1 drop/time, 5~6 times/day by symptom severity
-. HYALUNI ophthalmic solution 0.3% (sodium hyaluronate 0.3%), 1 drop/time, 5~6 times/day by symptom severity
-. RESTASIS 0.05% (cyclosporin 0.05%), 1 drop/time, 2 times/day with 12hr interval
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Primary Outcome(s)
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Changes in corneal staining score
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Secondary Outcome(s)
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Changes in corneal staining score
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Changes in meibomian gland dysfunction grading score
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Changes in OSDI score
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Changes in Schirmer's I test score
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Changes in conjunctival staining score
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Changes in TBUT (tear break-up time)
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Source(s) of Monetary Support
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Taejoon Pharm
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Ethics review
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Status: Submitted approval
Approval date:
Contact:
Sungmo Catholic Medical Center Institutional Review Board (SCMC IRB)
+82-2-3779-2011
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Results
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Results available:
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Yes |
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Date Posted:
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02/02/2016 |
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Date Completed:
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URL:
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