Back to resultsA Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
INS117548
INS117548
INS117548
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
One drop in each eye every 12 hours for seven days
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Outcomes
Primary Outcome Measures
Incidence of adverse events
Rate of discontinuation
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
Compliance
Secondary Outcome Measures
Full Information
NCT ID
NCT00767793
First Posted
October 2, 2008
Last Updated
October 1, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00767793
Brief Title
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
One drop in each eye every 12 hours for seven days
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One drop in each eye every 12 hours for seven days
Intervention Type
Drug
Intervention Name(s)
INS117548
Intervention Description
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention Type
Drug
Intervention Name(s)
INS117548
Intervention Description
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention Type
Drug
Intervention Name(s)
INS117548
Intervention Description
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
15
Title
Rate of discontinuation
Time Frame
15
Title
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
Time Frame
15
Title
Compliance
Time Frame
15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Haque, MD, PhD
Organizational Affiliation
Medical Monitor, Inspire
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
We'll reach out to this number within 24 hrs