臨床研究等提出・公開システム

Date of registration	Oct. 25, 2011
Last modified on	June. 07, 2021
Trial ID	jRCT2080221632

Scientific Title	Safety Study of OPC-12759 Ophthalmic Solution
Public Title	Safety Study of OPC-12759 Ophthalmic Solution

Completion Date or Terminated date	Dec. 18, 2011
Actual Enrolled Number	100
Baseline Characteristics
Participant flow	Of the 126 subjects who provided written informed consent to participate in the trial, 100 subjects who were judged to be eligible at the examination prior to initial instillation received the investigational medicinal product (IMP) in each eye (50 subjects each in the 2% OPC-12759 ophthalmic solution group and the 2% OPC-12759 ophthalmic suspension group). A total of 99 subjects completed the trial (49 subjects in the 2% OPC-12759 ophthalmic solution group and 50 subjects in the 2% OPC-12759 ophthalmic suspension group). One subject in the 2% OPC-12759 ophthalmic solution group was withdrawn from the trial after IMP administration (due to occurrence of an adverse event).
Adverse events	No serious or severe adverse events were reported in the 2% OPC-12759 ophthalmic solution group or the 2% OPC-12759 ophthalmic suspension group. In the 2% OPC-12759 ophthalmic solution group, 1 event in 1 subject resulted in the discontinuation of study instillation, and was considered to be a drug-related adverse event. This event was resolved, and all other adverse events and drug-related adverse events were resolving or resolved in both treatment groups.
Primary Outcome Measures	The incidence of white blurred vision after instillation, which was observed in the 2% OPC-12759 ophthalmic suspension group only, decreased, and the severity improved when the nasal root was pressed after instillation. The incidence of bitter taste was higher in the 2% OPC-12759 ophthalmic solution group than in the 2% OPC-12759 ophthalmic suspension group. When the nasal root was pressed after instillation, the incidence of bitter taste decreased and the severity improved in both groups. For both symptoms, no obvious differences in the time to onset or the duration were found between the instillations with and without nasal-root pressing.
Secondary Outcome Measures	-
Brief summary	2% OPC-12759 ophthalmic solution had no particular safety problems in the treatment for dry eye.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
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	Otsuka Pharmaceuticals Co., Ltd.
	Address	-
	Phone Number	-
	E-mail Address	CL_OPCJ_RDA_Team@otsuka.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Otsuka Pharmaceuticals Co., Ltd.
	Address	-
	Phone Number	+81-3-6361-7314
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Nov. 10, 2011
Target Sample Size		100
Study Type		Interventional
Study Design	Study Design	Treatment, Randomized, Crossover Assignment, Open Label, Safety Study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1.Gender: Male or Female 2.Age: 20 years and older (at the time of informed consent) 3.BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
	Exclusion Criteria	1.Presence of ocular disorder 2.Intraocular pressure of 21mmHg or higher 3.Corrected visual acuity of less than 1.0 4.Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow 5.History of refractive surgery 6.History of other ocular surgeries within 12 months 7.Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Dry eye syndromes
Intervention(s)		investigational material(s) Generic name etc : 2% OPC-12759 Ophthalmic solution INN of investigational material : Rebamipide Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : A single dose of OPC-12759 Ophthalmic solution for two-day treatment control material(s) Generic name etc : 2% OPC-12759 Ophthalmic suspension INN of investigational material : Rebamipide Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety The occurrences of blurred vision and dysgeusia
Secondary Outcome		-

Primary Sponsor	Otsuka Pharmaceuticals Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Osaka Pharmacology Clinical Research Hospital IRB
Address of IRB	-
Phone Number of IRB	+81-6-6395-9000
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Nov. 02, 2011

Secondary ID No.	NCT01471093
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-111674
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	June. 07, 2021	(this page)	Changes
9	Dec. 17, 2018	Detail	Changes
8	Feb. 24, 2012	Detail	Changes
7	Feb. 24, 2012	Detail	Changes
6	Dec. 27, 2011	Detail	Changes
5	Dec. 16, 2011	Detail	Changes
4	Nov. 11, 2011	Detail	Changes
3	Nov. 11, 2011	Detail	Changes
2	Oct. 25, 2011	Detail	Changes
1	Oct. 25, 2011	Detail

List of change history