Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.

Official Title
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A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Conditions
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Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Drug: INS115644 Ophthalmic Solution
* Drug: Placebo
* Drug: INS115644 Ophthalmic Solution
* Drug: INS115644 Ophthalmic Solution
* Drug: INS115644 Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma Have best corrected visual acuity in both eyes of at least +0.5 or better Have normal endothelial cell counts and morphology Exclusion Criteria: Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma Have a history of any type of intraocular surgery, except for cataract surgery Have had cataract surgery within three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Arm 1 | Drug: Placebo<br>* One drop of placebo in each eye every 12 hours for three days<br>|
| Experimental: 2<br>Arm 2 | Drug: INS115644 Ophthalmic Solution<br>* One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days<br>|
| Experimental: 3<br>Arm 3 | Drug: INS115644 Ophthalmic Solution<br>* One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days<br>|
| Experimental: 4<br>Arm 4 | Drug: INS115644 Ophthalmic Solution<br>* One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days<br>|
| Experimental: 5<br>Arm 5 | Drug: INS115644 Ophthalmic Solution<br>* One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 28 days | 
| Changes in intraocular pressure |  | 28 days | 

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