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

Glaucoma and Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687426
• Other study ID #: 12-150-0001
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2012
• Last updated: December 21, 2012
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Eye Therapies, LLC
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Brimonidine Tartrate 0.025%
1 drop in each eye daily four times a day for 14 days
• Vehicle
1 drop in each eye daily four times a day for 14 days

Locations

Country	Name	City	State
United States	Clinical Site	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eye Therapies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events as a Measure of Safety		For up to 8 weeks	Yes
Primary	IOP		14 days	No