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CompletedNCT00698945Updated Dec 4, 2008

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)

A Phase 4 interventional study of Istalol and Optive and Alphagan in Ocular Hypertension and Open-Angle Glaucoma, sponsored by Bp Consulting, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-04.

Sponsored by Bp Consulting, Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Ocular Hypertension
  • Open-Angle Glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Bp Consulting, Inc is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    2

    Alphagan

    Drug: Alphagan

  • Active comparator
    1

    Istalol and Optive

    Drug: Istalol and Optive

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

06

What researchers measure

Primary outcomes

  1. Trough and peak intraocular pressure

    Time frame: 2-4 months

Secondary outcomes

  1. Tolerability of study medication

    Time frame: 2-4 months

07

Study locations

1 site
  • North Bay Eye Associates, Inc.
    Petaluma, California 94954, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00698945
Lead sponsor
Bp Consulting, Inc
First posted
Jun 17, 2008
Start date
Jun 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Dec 4, 2008

Study contacts

Jason Bacharach, M.D
principal investigator · North Bay Eye Associates,Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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