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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105285
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : November 17, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: OPC-1085EL ophthalmic solution Drug: Carteolol long-acting ophthalmic solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Carteolol

Arm Intervention/treatment
Experimental: OPC-1085EL ophthalmic solution
Once daily
Drug: OPC-1085EL ophthalmic solution
Active Comparator: Carteolol long-acting ophthalmic solution
Once daily
Drug: Carteolol long-acting ophthalmic solution



Primary Outcome Measures :
  1. Decrease From Baseline in Intraocular Pressure at Week 8 Predose [ Time Frame: Baseline, Week 8 Predose ]
    Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.


Secondary Outcome Measures :
  1. Intraocular Pressure at Week 8 Predose [ Time Frame: Week 8 Predose ]

    Comparison of each group in intraocular pressure at Week 8 Predose. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

    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.

    Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

    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 8 hours after IMP administration.

    Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

    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.

    Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

    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. Change 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 Week 8 at 8 hours after IMP administration.

    Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group. As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105285


Locations
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Japan
Kansai Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02105285    
Other Study ID Numbers: 1085EL-13-003
First Posted: April 7, 2014    Key Record Dates
Results First Posted: November 17, 2015
Last Update Posted: December 28, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Carteolol
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents