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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00443924
First received: March 5, 2007
Last updated: January 19, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
Drug: INS115644 Ophthalmic Solution
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: March 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Arm 1
Drug: Placebo
One drop of placebo in each eye every 12 hours for three days
Experimental: 2
Arm 2
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
Experimental: 3
Arm 3
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
Experimental: 4
Arm 4
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
Experimental: 5
Arm 5
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00443924     History of Changes
Other Study ID Numbers: P08645, 032-101
Study First Received: March 5, 2007
Last Updated: January 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Bilateral ocular hypertension or early primary open angle glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015