A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma - Full Text View

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00767793

Purpose

The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.

Condition	Intervention	Phase
Glaucoma	Drug: Placebo Drug: INS117548	Phase I

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: 15 ] [ Designated as safety issue: No ]
Rate of discontinuation [ Time Frame: 15 ] [ Designated as safety issue: No ]
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters [ Time Frame: 15 ] [ Designated as safety issue: No ]
Compliance [ Time Frame: 15 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Placebo Comparator One drop in each eye every 12 hours for seven days	Drug: Placebo One drop in each eye every 12 hours for seven days
Arm 2: Experimental One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days	Drug: INS117548 One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm 3: Experimental One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days	Drug: INS117548 One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm 4: Experimental One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days	Drug: INS117548 One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767793

Contacts

Contact: Mike Schiewe

919-941-9777

Locations

United States, California
Sall Research Medical Center	Recruiting
Artesia, California, United States, 90701
United States, Florida
Visual Health & Surgical Center	Withdrawn
Lake Worth, Florida, United States, 33461
United States, Kentucky
Taustine Eye Center	Recruiting
Louisville, Kentucky, United States, 40217
United States, North Carolina
Mundorf Eye Center	Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
UPMC Eye Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Reza Haque, MD, PhD

Medical Monitor, Inspire

More Information

Responsible Party:	Inspire ( Mike Schiewe, Manager, Ophthalmic Clincial Research )
Study ID Numbers:	037-101
Study First Received:	October 2, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00767793
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009