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)

NCT00698945 | Completed Phase 4

• 1 other identifier: 5358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Trough and peak intraocular pressure

  2-4 months

Secondary Outcomes (1)

• Tolerability of study medication

  2-4 months

Study Arms (2)

2

ACTIVE COMPARATOR

Alphagan

Drug: Alphagan

1

ACTIVE COMPARATOR

Istalol and Optive

Drug: Istalol and Optive

Interventions

Istalol and Optive DRUG

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

1

Alphagan DRUG

Alphagan: two drops a day for 28 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bp Consulting, Inc: lead

Study Sites (1)

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Timolol; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jason Bacharach, M.D

  North Bay Eye Associates,Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 4, 2008

Record last verified: 2008-12

Locations

US (1)