Phase 1 Completed N=100 Randomized Treatment

Safety Study of OPC-12759 Ophthalmic Solution

Dry Eye Syndromes

Source: ClinicalTrials.gov NCT01471093 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcomePrimary: Number of Subjects With Blurred Vision After Instillation — 0; 10; 0; 21 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Blurred Vision After Instillation	0; 10; 0; 21	—
PRIMARY Number of Subjects With Bitter Taste	33; 23; 41; 29	—

Eligibility Criteria

Inclusion Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01471093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.