A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767793
• Other study ID #: P08650
• Secondary ID: 037-101
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2008
• Last updated: October 1, 2015
• Start date: September 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Placebo
One drop in each eye every 12 hours for seven days
• INS117548
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
• INS117548
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
• INS117548
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		15	No
Primary	Rate of discontinuation		15	No
Primary	Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters		15	No
Primary	Compliance		15	No