A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02348476
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 30.2

Study Details

Study Description

Brief Summary

This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Other: No Intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Simbrinza™ Patients treated with Simbrinza™ (brinzolamide 1%/brimonidine 0.2%) as standard of care in clinical practice. No study drug is administered in this study.	Other: No Intervention; No study drug is administered in this study.

Outcome Measures

Primary Outcome Measures

1. The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza® [2 Years]

Secondary Outcome Measures

1. The time to first glaucoma therapy escalation occurrence [2 Years]

2. The time(s) to additional glaucoma therapy escalation occurrence(s) [2 Years]

3. Specific AEs and SAEs occurring with a frequency of ≥5% [2 Years]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye

• Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation.

Exclusion criteria:

• Active ocular disease other than glaucoma or ocular hypertension

• History of any intraocular surgery or glaucoma laser surgery within 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Wheaton	Illinois	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02348476
• Other Study ID Numbers: GMA-SIM-14-024
• First Posted: Jan 28, 2015
• Last Update Posted: Sep 21, 2015
• Last Verified: Sep 1, 2015

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

Study Results

No Results Posted as of Sep 21, 2015