CompletedNCT01493180Updated Mar 10, 2015Results posted

Exploratory Study of OPC-12759 Ophthalmic Suspension

A Phase 2 interventional study of OPC-12759 ophthalmic suspension and Sodium hyaluronate ophthalmic solution in Keratoconjunctival Epithelial Disorder, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 10 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-03-10.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 102
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-12759 is to be assessed.

Conditions studied

Keratoconjunctival Epithelial Disorder

In context

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: No

Inclusion criteria

Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
Fluorescein corneal staining score of 3 or higher

Exclusion criteria

Exclusion Criteria:

Active ocular infection
Vernal keratoconjunctivitis
Recurrent corneal erosion
Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
Anticipated use of contact lens during the study.
Insertion of punctal plug or fall out of punctal plug within 3 months
Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
Receipt of any investigational product within 4 months.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 102 participants (actual)

Study arms

Experimental
OPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension
Drug: OPC-12759 ophthalmic suspension
Active comparator
Sodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution
Drug: Sodium hyaluronate ophthalmic solution

Interventions

DrugOPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension 2%
DrugSodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution 0.1%

What researchers measure

Primary outcomes

Change in the Keratoconjunctival Staining Score From Baseline
Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.
Time frame: Basekine, 4 weeks

Results

Posted Mar 3, 2014

Participant flow

Participant flow — Overall Study
Milestone	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution
Started	51	51
Completed	48	49
Not completed	3	2

Outcome measures

PrimaryChange in the Keratoconjunctival Staining Score From Baseline

Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.

Time frame:: Basekine, 4 weeks
Reported as:: Mean · scores on a scale

Change in the Keratoconjunctival Staining Score From Baseline
scores on a scale	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution
Change in the Keratoconjunctival Staining Score From Baseline	-3.4 ± 2.7	-3.1 ± 2.4

Statistical analysis

OPC-12759 Ophthalmic Suspension vs Sodium Hyaluronate Ophthalmic Solution · t-test, 2 sided · p = 0.576

Adverse events

Collected over 4 weeks. Non-serious events are listed at a 1.0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OPC-12759 Ophthalmic Suspension	—	1/51 (2%)	16/51 (31.4%)
Sodium Hyaluronate Ophthalmic Solution	—	0/51 (0%)	12/51 (23.5%)

Most frequent serious events

Most frequent serious events
Event	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution
MeningitisInfections and infestations	1/51	0/51

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution
Dysgeusia (bitter taste)Nervous system disorders	4/51	0/51
Conjunctivitis allergicEye disorders	3/51	3/51
ChalazionEye disorders	1/51	1/51
ConjunctivitisEye disorders	0/51	1/51
Corneal depositsEye disorders	1/51	0/51
Corneal infiltratesEye disorders	1/51	0/51
Eyelid oedemaEye disorders	1/51	0/51
Eye irritationEye disorders	0/51	1/51
KeratitisEye disorders	1/51	0/51
Punctate keratitisEye disorders	1/51	0/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution	Total
Mean	54.9 ± 17.9	54.5 ± 20.9	54.7 ± 19.3

Age, Categorical
Age, Categorical(Participants)	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution	Total
<=18 years	0	0	0
Between 18 and 65 years	31	27	58
>=65 years	20	24	44

Sex: Female, Male
Sex: Female, Male(Participants)	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution	Total
Female	41	34	75
Male	10	17	27

Region of Enrollment
Region of Enrollment(participants)	OPC-12759 Ophthalmic Suspension	Sodium Hyaluronate Ophthalmic Solution	Total
Japan	51	51	102

Study locations

10 sites

Kanto region
Hachioji, Japan
Kansai region
Ibaraki, Japan
Kansai region
Ikoma, Japan
Kansai Region
Kobe, Japan
Chugoku region
Kure, Japan
Kansai region
Kyoto, Japan
Tokai region
Nagoya, Japan
Kansai region
Osakasayama, Japan
Kansai region
Osaka, Japan
Kanto region
Tokyo, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01493180
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Dec 15, 2011
Start date: Dec 2011
Primary completion: Nov 2012
Completion: Dec 2012
Results posted: Mar 3, 2014
Last update: Mar 10, 2015

Study contacts

Eiji Murakami

study director · Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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