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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00443924

First received: March 5, 2007

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 5, 2007
Last Updated Date	September 20, 2011
Start Date ^ICMJE	March 2007
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2008)	Safety and tolerability [ Time Frame: 28 days ] [ Designated as safety issue: No ] Changes in intraocular pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 6, 2007)	Safety and tolerability Changes in intraocular pressure
Change History	Complete list of historical versions of study NCT00443924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Ocular Hypertension Open Angle Glaucoma
Intervention ^ICMJE	Drug: INS115644 Ophthalmic Solution One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days Drug: Placebo One drop of placebo in each eye every 12 hours for three days Drug: INS115644 Ophthalmic Solution One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days Drug: INS115644 Ophthalmic Solution One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days Drug: INS115644 Ophthalmic Solution One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
Study Arm (s)	Placebo Comparator: 1 Arm 1 Intervention: Drug: Placebo Experimental: 2 Arm 2 Intervention: Drug: INS115644 Ophthalmic Solution Experimental: 3 Arm 3 Intervention: Drug: INS115644 Ophthalmic Solution Experimental: 4 Arm 4 Intervention: Drug: INS115644 Ophthalmic Solution Experimental: 5 Arm 5 Intervention: Drug: INS115644 Ophthalmic Solution
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	42
Completion Date	Not Provided
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00443924
Other Study ID Numbers ^ICMJE	032-101, P08645
Has Data Monitoring Committee	Not Provided
Responsible Party	Mike Schiewe, Inspire Pharmaceuticals
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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