Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

• Sponsor: Eye Therapies, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01687426
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma and Ocular Hypertension	Drug: Brimonidine Tartrate 0.025%; Drug: Vehicle	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Brimonidine Tartrate 0.025%	Drug: Brimonidine Tartrate 0.025%; 1 drop in each eye daily four times a day for 14 days; Drug: Vehicle; 1 drop in each eye daily four times a day for 14 days
Placebo Comparator: Vehicle	Drug: Brimonidine Tartrate 0.025%; 1 drop in each eye daily four times a day for 14 days; Drug: Vehicle; 1 drop in each eye daily four times a day for 14 days

Outcome Measures

Primary Outcome Measures

1. IOP [14 days]

Other Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety [For up to 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age at Visit 1 (Screening), of either sex and any race

• Be willing and able to provide written informed consent prior to any study procedures being performed.

• Be willing and able to follow all instructions and attend all study visits.

• Be willing to discontinue use of disallowed medication

• Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.

Exclusion Criteria:

• Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.

• Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Winchester	Massachusetts	United States	01890

Sponsors and Collaborators

• Eye Therapies, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eye Therapies, LLC
• ClinicalTrials.gov Identifier: NCT01687426
• Other Study ID Numbers: 12-150-0001
• First Posted: Sep 19, 2012
• Last Update Posted: Dec 25, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Brimonidine Tartrate

Study Results

No Results Posted as of Dec 25, 2012