DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

Study Overview
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Brief Summary
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DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Official Title
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A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: DE-111 ophthalmic solution
* Drug: Tafluprost ophthalmic solution 0.0015%
* Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with primary open angle glaucoma or ocular hypertension Provided signed, written informed consent 20 years of age and older If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DE-111 ophthalmic solution | Drug: DE-111 ophthalmic solution<br> <br> |
| Active Comparator: 2<br>Tafluprost ophthalmic solution 0.0015% | Drug: Tafluprost ophthalmic solution 0.0015%<br> <br> |
| Active Comparator: 3<br>Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% | Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study | Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30. | Week 0(Baseline) and Week 4(End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary open angle glaucoma or ocular hypertension