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)

• Sponsor: Bp Consulting, Inc (Other)
• Overall Status: Completed
• CT.gov ID: NCT00698945
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension; Open-Angle Glaucoma	Drug: Istalol and Optive; Drug: Alphagan	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Alphagan	Drug: Alphagan; Alphagan: two drops a day for 28 days
Active Comparator: 1 Istalol and Optive	Drug: Istalol and Optive; Istalol: one drop a day for 28 days Optive: one drop a day for 28 days

Outcome Measures

Primary Outcome Measures

1. Trough and peak intraocular pressure [2-4 months]

Secondary Outcome Measures

1. Tolerability of study medication [2-4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Bay Eye Associates, Inc.	Petaluma	California	United States	94954

Sponsors and Collaborators

• Bp Consulting, Inc

Investigators

• Principal Investigator: Jason Bacharach, M.D, North Bay Eye Associates,Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00698945
• Other Study ID Numbers: 5358
• First Posted: Jun 17, 2008
• Last Update Posted: Dec 4, 2008
• Last Verified: Dec 1, 2008

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Brimonidine Tartrate

Study Results

No Results Posted as of Dec 4, 2008