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)”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Istalol and Optive
  • Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
• Drug: Alphagan
  • Alphagan: two drops a day for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Alphagan
• Active Comparator: 1
  • Istalol and Optive

Primary Measures

• Trough and peak intraocular pressure
  • Time Frame: 2-4 months
    Safety Issue?: No

Secondary Measures

• Tolerability of study medication
  • Time Frame: 2-4 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bp Consulting, Inc

Overall Clinical Trial Officials and Contacts

Jason Bacharach, M.D Principal Investigator North Bay Eye Associates,Inc.  

Overall Contact: Michelle Chabot 714-246-9581 michelle_bpconsulting@yahoo.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698945

Study ID Number: 5358

ClinicalTrials.gov Identifier: NCT00698945

Health Authority: United States: Institutional Review Board