Ocular HypertensionPhase 4NCT00698945
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 study testing Istalol and Optive and Alphagan in people with Ocular Hypertension and Open-Angle Glaucoma, run by Bp Consulting, Inc at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Hypertension, Open-Angle Glaucoma
- What is being tested?
- Istalol and Optive and Alphagan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
North Bay Eye Associates, Inc.
Petaluma, California, 94954
About this study
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)
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).
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- Istalol and Optive, Alphagan
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istalol and OptiveDrug
Istalol: one drop a day for 28 days Optive: one drop a day for 28 days
AlphaganDrug
Alphagan: two drops a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Alphagan Receives: Drug: Alphagan |
| 1 | Active comparator | Istalol and Optive Receives: Drug: Istalol and Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough and peak intraocular pressure
Measured: 2-4 months
Secondary outcomes (1)
Tolerability of study medication
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Investigators
- Jason Bacharach, M.D, Principal investigator, North Bay Eye Associates,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698945
- Sponsor's protocol ID
- 5358
- Status last verified
- Dec 2008
- First submitted
- 13 Jun 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00698945
- Acronym / sponsor ID
- 5358
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: AlphaganAlphagan |
| 1 | Active comparator | Drug: Istalol and OptiveIstalol and Optive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Istalol and OptiveIstalol: one drop a day for 28 days Optive: one drop a day for 28 days | Drug | 1 |
| AlphaganAlphagan: two drops a day for 28 days | Drug | 2 |
Primary outcome
Trough and peak intraocular pressure
Time frame: 2-4 months
1 secondary outcome
Tolerability of study medication
Time frame: 2-4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Bacharach, M.D principal investigator
North Bay Eye Associates,Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Istalol and Optive and Alphagan in people with Ocular Hypertension and Open-Angle Glaucoma, run by Bp Consulting, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough and peak intraocular pressure (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2008.