The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure

NCT02165631 | Completed

• 2 other identifiers: 14-0362UL1TR001082
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and nocturnal periods. The primary aim of this study will be to determine the effects of Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to compare these to those of timolol.

Conditions

Open Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Syndrome; Pseudoexfoliation Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure Group A

  The primary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of Simbrinza therapy at multiple time points throughout a 24-hour period.

  24 hours

Secondary Outcomes (1)

• Intraocular pressure Group B

  24 hours

Study Arms (2)

Group A-Simbinza

Patients in Group A will receive Simbrinza (brinzolamide) 1%/0.2%, with instruction for three times daily (every 8hours) administration of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.

Group B-Timolol

Patients in Group B will receive Timolol 0.5%, with instructions for twice daily administration (every 12 hours) of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Open angle glaucoma, Ocular hypertension,Pigment dispersion glaucoma, or Pseudoexfoliation glaucoma

You may qualify if:

• Diagnosis of open angle glaucoma or ocular hypertension including pigment dispersion glaucoma and pseudoexfoliation glaucoma.
• Age ≥ 18 years, of either gender, or any race/ethnicity

You may not qualify if:

• Females who are currently pregnant or planning to become pregnant during the study period
• Contraindications to beta blockers (see below)
• Patients currently taking oral beta blocker therapy
• Diagnosis of any other form of glaucoma other than open-angle
• Schaffer angle grade \< 2 in either eye by gonioscopy
• Intraocular surgery within 6 months or laser within 3 months
• Inability to safely discontinue all ocular medications for 6 weeks
• Patients who smoke or have irregular daily sleep patterns
• History of allergy or intolerance to topical carbonic anhydrase inhibitors, or alpha-agonists
• Patients who have started or changed glucocorticoids therapy in the last 3 months
• Patients who are currently using medical or recreational marijuana
• Any use of a non-FDA approved medication for glaucoma in the last 3 months

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma-Related Pigment Dispersion Syndrome; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Malik Y Kahook, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)