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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)

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00698945
First received: June 13, 2008
Last updated: December 2, 2008
Last verified: December 2008
History of Changes
  Purpose

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).


Condition Intervention Phase
Ocular Hypertension
Open-Angle Glaucoma
 Drug: Istalol and Optive
Drug: Alphagan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Trough and peak intraocular pressure [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of study medication [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Alphagan
 Drug: Alphagan
Alphagan: two drops a day for 28 days
Active Comparator: 1
Istalol and Optive
 Drug: Istalol and Optive
Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698945

Locations
United States, California
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
Sponsors and Collaborators
Bp Consulting, Inc
Investigators
Principal Investigator: Jason Bacharach, M.D North Bay Eye Associates,Inc.
  More Information

No publications provided

Responsible Party: Dr. Bacharach, North Bay Eye Associates, Inc.
ClinicalTrials.gov Identifier: NCT00698945     History of Changes
Other Study ID Numbers: 5358
Study First Received: June 13, 2008
Last Updated: December 2, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Latanoprost
Sorbitol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Cathartics
Gastrointestinal Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on May 16, 2013