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)
Information source: Bp Consulting, Inc
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ocular Hypertension; Open-Angle Glaucoma
Intervention: Istalol and Optive (Drug); Alphagan (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bp Consulting, Inc Official(s) and/or principal investigator(s):
Jason Bacharach, M.D, Principal Investigator, Affiliation: North Bay Eye Associates,Inc.
Overall contact:
Michelle Chabot, Phone: 714-246-9581, Email: michelle_bpconsulting@yahoo.com
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).
Clinical Details
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 design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
Primary outcome: Trough and peak intraocular pressure
Secondary outcome: Tolerability of study medication
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Michelle Chabot, Phone: 714-246-9581, Email: michelle_bpconsulting@yahoo.com
North Bay Eye Associates, Inc., Petaluma, California 94954, United States; Recruiting
Jason Bacharach, M.D, Phone: 707-762-3573, Email: michelle_bpconsulting@yahoo.com
Additional Information
Starting date: June 2008
Last updated: June 16, 2008
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