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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698945

Enrollment

Registered

2008-06-17

Start date

2008-06-30

Completion date

2008-11-30

Last updated

2008-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-Angle Glaucoma

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).

Interventions

DRUGIstalol and Optive

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

DRUGAlphagan

Alphagan: two drops a day for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Trough and peak intraocular pressure	2-4 months

Secondary

Measure	Time frame
Tolerability of study medication	2-4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026