Comparison of Istalol™ 0.5% QD (Timolol Maleate/Sorbitol... | NCT00698945

Studies
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

Sponsor

Bp Consulting, Inc

Status

Completed

Last Update Posted

Dec 4, 2008Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Ocular Hypertension
Open-Angle Glaucoma

Interventions

Istalol and Optive
Alphagan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2008

Last Update Posted Date

Dec 4, 2008Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Alphagan	Drug: Alphagan
1	Active Comparator	Istalol and Optive	Drug: Istalol and Optive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Istalol and Optive	Drug	Istalol: one drop a day for 28 days Optive: one drop a day for 28 days	1

Measure	Description	Time Frame
Trough and peak intraocular pressure		2-4 months

Measure	Description	Time Frame
Tolerability of study medication		2-4 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Mar 5, 2012
Reset	Apr 4, 2012

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

ID	Term
D005128	Eye Diseases
D005901	Glaucoma

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D020005	Propanols
D000588	Amines
D013830	Thiadiazoles
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009025	Morpholines
D010078	Oxazines
D011810	Quinoxalines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D013999	Timolol
D000068438	Brimonidine Tartrate