CompletedNCT01471093Updated Jun 29, 2021Results posted

Safety Study of OPC-12759 Ophthalmic Solution

A Phase 1 interventional study of OPC-12759 Ophthalmic solution and OPC-12759 Ophthalmic suspension in Dry Eye Syndromes, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-29.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

Conditions studied

Dry Eye Syndromes

Browse trials for

Dry Eye Syndromes 1,292

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Exclusion criteria

Exclusion Criteria:

Presence of ocular disorder
Intraocular pressure of 21mmHg or higher
Corrected visual acuity of less than 1.0
Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
History of refractive surgery
History of other ocular surgeries within 12 months
Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 100 participants (actual)

Study arms

Experimental
Solution
A single dose of OPC-12759 Ophthalmic solution for two-day treatment
Drug: OPC-12759 Ophthalmic solution
Active comparator
Suspension
A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Drug: OPC-12759 Ophthalmic suspension

Interventions

DrugOPC-12759 Ophthalmic solution
2％ OPC-12759 Ophthalmic solution
DrugOPC-12759 Ophthalmic suspension
2％ OPC-12759 Ophthalmic suspension

What researchers measure

Primary outcomes

Number of Subjects With Blurred Vision After Instillation
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Time frame: The first and second instillation
Number of Subjects With Bitter Taste
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Time frame: The first and second instillation

Results

Posted Jun 29, 2021

Participant flow

This study was a single-center, randomized, crossover, open-label study.

Participant flow — Overall Study
Milestone	OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed	OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed	OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed	OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed
Started	25	25	25	25
Completed	24	25	25	25
Not completed	1	0	0	0
Withdrew: Adverse event	1	0	0	0

Outcome measures

PrimaryNumber of Subjects With Blurred Vision After Instillation

The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.

Time frame:: The first and second instillation
Reported as:: Number · participants

Number of Subjects With Blurred Vision After Instillation
participants	OPC-12759 Solution With Nasal Root Pressed/Not Pressed	OPC-12759 Suspension With Nasal Root Pressed/Not Pressed
With Nasal Root Press	0	10
Without Nasal Root Press	0	21

PrimaryNumber of Subjects With Bitter Taste

The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.

Time frame:: The first and second instillation
Reported as:: Number · participants

Number of Subjects With Bitter Taste
participants	OPC-12759 Solution With Nasal Root Pressed/Not Pressed	OPC-12759 Suspension With Nasal Root Pressed/Not Pressed
With Nasal Root Press	33	23
Without Nasal Root Press	41	29

Adverse events

Collected over Treatment period (2 days up to 15 days). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OPC-12759 Solution	0/50 (0%)	0/50 (0%)	6/50 (12%)
OPC-12759 Suspension	0/50 (0%)	0/50 (0%)	2/50 (4%)

Most frequent other events

Most frequent other events
Event	OPC-12759 Solution	OPC-12759 Suspension
ChalazionEye disorders	0/50	1/50
Herpes zosterInfections and infestations	1/50	0/50
NasopharyngitisInfections and infestations	1/50	0/50
Aspartate aminotransferase increasedInvestigations	1/50	0/50
Blood bilirubin increasedInvestigations	1/50	0/50
Blood lactate dehydrogenase increasedInvestigations	1/50	0/50
Protein urine presentInvestigations	0/50	1/50
Blood alkaline phosphatase increasedInvestigations	1/50	0/50
HeadacheNervous system disorders	0/50	1/50
Rash pruriticSkin and subcutaneous tissue disorders	1/50	0/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)	OPC-12759 Solution	OPC-12759 Suspension	Total
Mean	27.8 ± 6.3	25.9 ± 6.3	26.9 ± 6.3

Sex: Female, Male
Sex: Female, Male(Participants)	OPC-12759 Solution	OPC-12759 Suspension	Total
Female	28	27	55
Male	22	23	45

Region of Enrollment
Region of Enrollment(Participants)	OPC-12759 Solution	OPC-12759 Suspension	Total
Japan	50	50	100

Study locations

1 site

Kansai region
Osaka, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01471093
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Nov 11, 2011
Start date: Nov 2011
Primary completion: Dec 2011
Completion: Feb 2012
Results posted: Jun 29, 2021
Last update: Jun 29, 2021

Study contacts

Eiji Murakami

study chair · Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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