Safety Study of OPC-12759 Ophthalmic Solution

Dry Eye Syndromes Clinical Trial

Official title:

Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471093
• Other study ID #: 037E-11-004
• Secondary ID: JapicCTI-111674
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Dry Eye Syndromes

Intervention

Drug:
• OPC-12759 Ophthalmic solution
2% OPC-12759 Ophthalmic solution
• OPC-12759 Ophthalmic suspension
2% OPC-12759 Ophthalmic suspension

Locations

Country	Name	City	State
Japan	Kansai region	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The first and second instillation
Primary	Number of Subjects With Bitter Taste	The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.	The first and second instillation