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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00443924
First received: March 5, 2007
Last updated: September 20, 2011
Last verified: September 2011

March 5, 2007
September 20, 2011
March 2007
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety and tolerability
  • Changes in intraocular pressure
Complete list of historical versions of study NCT00443924 on ClinicalTrials.gov Archive Site
Not Provided
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Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open Angle Glaucoma
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00443924
032-101, P08645
Not Provided
Mike Schiewe, Inspire Pharmaceuticals
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP