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OpenTrials
Completed

NCT Number: 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)

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Istalol and Optive

Drug

Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

Alphagan

Drug

Alphagan: two drops a day for 28 days

Primary outcomes

  1. Trough and peak intraocular pressure

    Time frame: 2-4 months

Secondary outcomes

  1. Tolerability of study medication

    Time frame: 2-4 months

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 17, 2008
Registry last updated
Dec 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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