Phase 1
N=100
Safety Study of OPC-12759 Ophthalmic Solution
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01471093 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Subjects With Blurred Vision After Instillation — 0; 10; 0; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OPC-12759 Ophthalmic solution (Drug); OPC-12759 Ophthalmic suspension (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2011
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 | — |
Summary
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
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
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.