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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)

Primary Purpose

Ocular Hypertension, Open-Angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Istalol and Optive
Alphagan
Sponsored by
Bp Consulting, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North Bay Eye Associates, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2

1

Arm Description

Alphagan

Istalol and Optive

Outcomes

Primary Outcome Measures

Trough and peak intraocular pressure

Secondary Outcome Measures

Tolerability of study medication

Full Information

First Posted
June 13, 2008
Last Updated
December 2, 2008
Sponsor
Bp Consulting, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00698945
Brief 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)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bp Consulting, Inc

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Alphagan
Arm Title
1
Arm Type
Active Comparator
Arm Description
Istalol and Optive
Intervention Type
Drug
Intervention Name(s)
Istalol and Optive
Intervention Description
Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Alphagan
Intervention Description
Alphagan: two drops a day for 28 days
Primary Outcome Measure Information:
Title
Trough and peak intraocular pressure
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
Tolerability of study medication
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Bacharach, M.D
Organizational Affiliation
North Bay Eye Associates,Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

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