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Completed

NCT Number: NCT02105272

Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kansai Region, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion criteria

  • Subjects with ocular conditions as defined by the protocol

Treatment and study plan

OPC-1085EL ophthalmic solution

Drug

Latanoprost ophthalmic solution

Drug

Primary outcomes

  1. Decrease From Baseline in Intraocular Pressure

    Time frame: Baseline, week 8 predose

Secondary outcomes

  1. Intraocular Pressure at Week 8 Predose

    Time frame: Week 8 Predose

    Comparison of each group in intraocular pressure at Week 8 Predose. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

  2. Intraocular Pressure at Week 8 at 2 Hours After IMP Administration

    Time frame: Week 8 at 2 hours after IMP administration

    Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.

    The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

  3. Intraocular Pressure at Week 8 at 8 Hours After IMP Administration

    Time frame: Week 8 at 8 hours after IMP administration

    Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.

    The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

  4. Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration

    Time frame: Baseline, Week 8 at 2 hours after IMP administration

    Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.

    The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

  5. Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration

    Time frame: Baseline, Week 8 at 8 hours after IMP administration

    Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.

    The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2014
Registry last updated
Dec 21, 2015

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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