Clinical trial NCT00698945: Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)
Official title: Randomized, Investigator Masked Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol Complex, ISTA Pharmaceutical) to Brimonidine Tartrate 0.1% BID as Adjunctive Therapy to Latanoprost 0.005% in Adults With Ocular Hypertension (OHT) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ocular Hypertension
Open-Angle Glaucoma
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the additional benefit of common adjunctive classes on the diurnal IOP curve in patients assessed as needing additional treatment to reach target intraocular pressure (IOP). To demonstrate superiority of IOP control with Istalol 0.5% QD compared to Brimonidine Tartrate 0.2% BID as adjunctive therapy in adults with uncontrolled IOP's (determined by P.I. based on target pressures) currently treated with Latanoprost 0.05% in the study eye(s).


Eligibility criteria: Inclusion Criteria:

1. Patients, male or female of any race or ethnicity, 18 years of age or older, diagnosed with ocular hypertension or open-angle glaucoma (with or without pseudoexfoliative or pigmentary dispersion component).
2. Stable use of Latanoprost 0.005% for a minimum of 30 days prior to screening visit.
3. VA of 20/200 or better in either eye
4. Pachymetry of 600 microns or less
5. Visual Field within 6 months of screening visit
6. Patients who use contact lenses are allowed to participate provided that they will remove lenses 15 minutes before dosing
7. Patients who satisfy all informed consent requirements may be included in the study.

Exclusion Criteria:

1. Females of childbearing potential (those who are not surgically sterile, postmenopausal or using a reliable birth control method) will be excluded from the study.
2. Any allergic component or contraindication to the study medications
3. Pachymetry of 600 microns or greater
4. Systemic corticosteroids not on a stable regimen within 30 days of screening visit.
5. Any concurrent topical agents that can not be discontinued during the course of the trial (natural tears are acceptable)
6. Significant ocular surface abnormalities
7. Patients with any form of glaucoma other than ocular hypertension or open-angle glaucoma
8. Patients who have been on an investigational therapy within 30 days prior to screening visit
9. History of ocular trauma within the past 3 months
10. Intraocular surgery within the past 3 months
11. Ocular laser surgery within the past 3 months
12. Any abnormality preventing reliable applanation tonometry of either eye
13. VA of 20/200 or greater in either eye
14. History or evidence of clinically significant illness or conditions which would make the patient, in the opinion of the investigator, not suitable for the study

Primary outcomes:
measure: Trough and peak intraocular pressure
timeFrame: 2-4 months
Secondary outcomes:
measure: Tolerability of study medication
timeFrame: 2-4 months
Other outcomes:
Locations:
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
Study officials:
affiliation: North Bay Eye Associates,Inc.
name: Jason Bacharach, M.D
role: PRINCIPAL_INVESTIGATOR
References: