Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
January 19, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
Arm 1
|
One drop of placebo in each eye every 12 hours for three days
|
|
Experimental: 2
Arm 2
|
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
|
|
Experimental: 3
Arm 3
|
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
|
|
Experimental: 4
Arm 4
|
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
|
|
Experimental: 5
Arm 5
|
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and tolerability
Time Frame: 28 days
|
28 days
|
|
Changes in intraocular pressure
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 6, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Estimate)
January 21, 2015
Last Update Submitted That Met QC Criteria
January 19, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P08645
- 032-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.