Title

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)
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)
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    40
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 Started
Jun 30
2008
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
Dec 04
2008
Estimate

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

2 Active Comparator

Alphagan

1 Active Comparator

Istalol and Optive

Criteria

Inclusion Criteria:

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).
Stable use of Latanoprost 0.005% for a minimum of 30 days prior to screening visit.
VA of 20/200 or better in either eye
Pachymetry of 600 microns or less
Visual Field within 6 months of screening visit
Patients who use contact lenses are allowed to participate provided that they will remove lenses 15 minutes before dosing
Patients who satisfy all informed consent requirements may be included in the study.

Exclusion Criteria:

Females of childbearing potential (those who are not surgically sterile, postmenopausal or using a reliable birth control method) will be excluded from the study.
Any allergic component or contraindication to the study medications
Pachymetry of 600 microns or greater
Systemic corticosteroids not on a stable regimen within 30 days of screening visit.
Any concurrent topical agents that can not be discontinued during the course of the trial (natural tears are acceptable)
Significant ocular surface abnormalities
Patients with any form of glaucoma other than ocular hypertension or open-angle glaucoma
Patients who have been on an investigational therapy within 30 days prior to screening visit
History of ocular trauma within the past 3 months
Intraocular surgery within the past 3 months
Ocular laser surgery within the past 3 months
Any abnormality preventing reliable applanation tonometry of either eye
VA of 20/200 or greater in either eye
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
No Results Posted