臨床研究等提出・公開システム

Date of registration	Mar. 03, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080222777

Scientific Title	XED-60 in the treatment of dry eye, Phase2 study.
Public Title	XED-60 in the treatment of dry eye, Phase2 study.

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Lion Corporation
	Address	0120-813-752
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		60
Study Type		Interventional
Study Design	Study Design	A randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase2 study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Males or Females (2) 15years old or older (3) Out patient (4) Meet the diagnostic criteria (Definition and Diagnosis of Dry Eye 2006) of the Japanese Dry Eye Research group (5) Dryness score of dry eye-related ocular symptoms 2 point or over
	Exclusion Criteria	(1) Stevens-Johnson syndrome and ocular pemphigoid (2) Chemical or thermal burns (3) Other ocular diseases (4) Allogeneic heamatopoietic stem cell transplantation (5) Any history of ocular surgery within 3 months (6) Refractive corneal surgery (7) Patient with punctal plug (8) Female patients who are pregnant, possibly pregnant or breast feeding (9) Known hypersensitivity to any component of the study drug or procedual medications (10) Glaucoma patient (11) Anticipated use of contact lens during the study (12) Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study (13) Any systemic disease
	Minimum Age	15age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Dry eye
Intervention(s)		investigational material(s) Generic name etc : XED-60 INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : Instillation, 6times/day for 4weeks control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Instillation, 6times/day for 4weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		The change in dry eye symptom score (dryness), fluorescein and rose bengal staining scores from baseline at the 4-week endpoint (last observation carried forward).
Secondary Outcome		The change in subjective dry eye symptom score (11 parameters: foreign body sensation, photophobia, itching, eye pain, heaviness, blurred vision, eye fatigue, eye discomfort, eye discharge, hyperemia and lacrimation), BUT and Schirmer's test result from baseline at the 4-week endpoint (last observation carried forward).

Primary Sponsor	Lion Corporation
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	Juntendo University Hospital
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Name	Juntendo Tokyo Kotoh GeriatricMedical Center
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Name	Yokohama MINORU Clinic
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-152829
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Mar. 18, 2016	Detail	Changes
3	Mar. 18, 2016	Detail	Changes
2	Mar. 03, 2015	Detail	Changes
1	Mar. 03, 2015	Detail

List of change history