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

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

INS115644 Ophthalmic Solution

Placebo

INS115644 Ophthalmic Solution

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring Bilateral ocular hypertension or early primary open angle glaucoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Safety and tolerability

Changes in intraocular pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00443924

First Posted

March 5, 2007

Last Updated

January 19, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00443924

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Hypertension, Open Angle Glaucoma

Keywords

Bilateral ocular hypertension or early primary open angle glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Arm 1

Arm Title

Arm Type

Experimental

Arm Description

Arm 2

Arm Title

Arm Type

Experimental

Arm Description

Arm 3

Arm Title

Arm Type

Experimental

Arm Description

Arm 4

Arm Title

Arm Type

Experimental

Arm Description

Arm 5

Intervention Type

Drug

Intervention Name(s)

INS115644 Ophthalmic Solution

Intervention Description

One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One drop of placebo in each eye every 12 hours for three days

Intervention Type

Drug

Intervention Name(s)

INS115644 Ophthalmic Solution

Intervention Description

One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days

Intervention Type

Drug

Intervention Name(s)

INS115644 Ophthalmic Solution

Intervention Description

One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days

Intervention Type

Drug

Intervention Name(s)

INS115644 Ophthalmic Solution

Intervention Description

One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days

Primary Outcome Measure Information:

Title

Safety and tolerability

Time Frame

28 days

Title

Changes in intraocular pressure

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

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

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