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)

Ocular Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698945
• Other study ID #: 5358
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: December 2, 2008
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Istalol and Optive
Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
• Alphagan
Alphagan: two drops a day for 28 days

Locations

Country	Name	City	State
United States	North Bay Eye Associates, Inc.	Petaluma	California

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough and peak intraocular pressure		2-4 months
Secondary	Tolerability of study medication		2-4 months