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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165631
• Other study ID #: 14-0362
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: March 10, 2016
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Intraocular pressure (IOP) is a major risk factor for the development of glaucoma. In addition, it is the only modifiable factor in the prevention and subsequent treatment of glaucomatous optic neuropathy. Most clinicians only have access to a single IOP measurement during a patient visit that may only occur once every four months. These snapshots in time are probably not adequate for the optimal management of glaucoma. Diurnal IOP curves can provide a better estimate of each patient's individual IOP variation throughout the day. However diurnal curves do not typically cover another crucial time, the nocturnal period. Glaucomatous eyes have been shown to have different IOP curves during the nocturnal period compared to healthy controls. In addition, different classes of glaucoma drugs have variable IOP lowering effects during the nocturnal hours compared to the diurnal/wake period. For example, the betablocker timolol was shown to lower IOP during daytime hours but failed to lower IOP during the nocturnal period in the habitual position. Similarly, the alpha-agonist brimonidine failed to lower IOP overnight after significantly lowering IOP during the diurnal period. On the other hand, the prostaglandin analogues, including latanoprost and travoprost, lowered IOP throughout the diurnal and nocturnal periods although nocturnal lowering appears less than the daytime hours. Therefore it is crucial to determine an accurate IOP curve for each form of medication during both wake and sleep hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma
• Pigment Dispersion Syndrome
• Pseudoexfoliation Glaucoma

Locations

Country	Name	City	State
United States	University of Colorado Eye Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intraocular pressure Group B	The secondary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of timolol therapy at multiple time points throughout a 24-hour period, and how this compares to similar effects by Simbrinza.	24 hours	No