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Completed

NCT Number: NCT01471093

Safety Study of OPC-12759 Ophthalmic Solution

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kansai region

Osaka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPC-12759 Ophthalmic solution

Drug

2％ OPC-12759 Ophthalmic solution

OPC-12759 Ophthalmic suspension

Drug

2％ OPC-12759 Ophthalmic suspension

Primary outcomes

  1. Number of Subjects With Blurred Vision After Instillation

    Time frame: The first and second instillation

    The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.

  2. Number of Subjects With Bitter Taste

    Time frame: The first and second instillation

    The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 11, 2011
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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