Safety Study of OPC-12759 Ophthalmic Solution

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221632

Enrollment

100

Registered

2011-10-25

Start date

2011-11-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye syndromes

Interventions

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 Admini

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
safety The occurrences of blurred vision and dysgeusia	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026