Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

An observational study of Glaucoma, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Glaucoma
What is being tested?: (Cosopt®, prostaglandin)
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Oct 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Glaucoma patients

Who may be able to join

Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
glaucomatous optic disc cupping
agreement between two baseline exams for reliability
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards.

Who cannot join

Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
Evidence of exfoliation or pigment dispersion.
History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.

Show all 11Show fewer

Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Cataract surgery within the past year.
Resting pulse < 50 beats per minute.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University School of Medicine, Department of Ophthalmology
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Read the detailed description

Conditions: Glaucoma
Being tested: (Cosopt®, prostaglandin)
Keywords: Glaucoma, Cosopt, blood flow, progression
Medical subject headings: Glaucoma, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(Cosopt®, prostaglandin)Drug
Also called Cosopt is a trade name drug which is a combination of dorzolamide and timolol.
We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.

Study groups in NCT01145898
Study group	Role	What they receive
Glaucoma patients		Patients with Glaucoma Receives: Drug: (Cosopt®, prostaglandin)

What is being measured

The primary outcome is the main question the study is designed to answer.

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
Measured: Baseline and 6 month visits
6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
Measured: Baseline and 6 month visits
6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)
Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
Measured: Baseline and 6 month visits
6-month Change in Ocular Perfusion Pressures (OPP)
Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.
Measured: Baseline and 6 month visits
3-year Change in OA PSV
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
Measured: Baseline and 36 month visits
3-year Change in OA EDV
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
Measured: Baseline and 36 month visits
3-year Change in OA RI
Measurement of change in ocular blood flow - ophthalmic artery resistance index
Measured: Baseline and 36 month visits
3-year Change in CRA PSV
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
Measured: Baseline and 36 month visits
3-year Change in CRA EDV
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
Measured: Baseline and 36 month visits
3-year Change in CRA RI
Measurement of change in ocular blood flow - central retinal arteries resistance index
Measured: Baseline and 36 month visits
3-year Change in OPP
Measurement of change in ocular perfusion pressure
Measured: Baseline and 36 month visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Oct 2012

First posted17 Jun 2010 (estimated)
Study startJun 2010
Primary completionJan 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145898
Sponsor's protocol ID: Cosopt and OAG progression
Status last verified: Jan 2014
First submitted: 15 Jun 2010
Last updated: 22 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
ClinicalTrials.gov ID: NCT01145898
Acronym / sponsor ID: Cosopt and OAG progression
Conditions: Glaucoma
Keywords: Glaucoma, Cosopt, blood flow, progression
Study type: Observational
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Jun 2010
Primary completion: Jan 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 17 Jun 2010 (estimated)
Results: Posted 22 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Glaucoma patients	–	Drug: (Cosopt®, prostaglandin)Patients with Glaucoma

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Glaucoma patients

Key inclusion criteria (7 listed)

Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards.

Key exclusion criteria (11 listed)

Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
Evidence of exfoliation or pigment dispersion.
History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.

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
(Cosopt®, prostaglandin)Also: Cosopt is a trade name drug which is a combination of dorzolamide and timolol.We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.	Drug	Glaucoma patients

Primary outcome

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Time frame: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
6-month Change in Ocular Perfusion Pressures (OPP)
Time frame: Baseline and 6 month visits
Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.
3-year Change in OA PSV
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
3-year Change in OA EDV
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
3-year Change in OA RI
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery resistance index
3-year Change in CRA PSV
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
3-year Change in CRA EDV
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
3-year Change in CRA RI
Time frame: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries resistance index
3-year Change in OPP
Time frame: Baseline and 36 month visits
Measurement of change in ocular perfusion pressure

Results and safety

Results posted to the registry on 22 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trusopt	12	12
Prostaglandin Alone	44	44

Primary outcome: 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Trusopt n = 12	Prostaglandin Alone n = 44
Value	2.32 (1.20)	-.30 (1.17)

Trusopt vs Prostaglandin Alone: p = .6261, ANCOVA

Primary outcome: 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Trusopt n = 12	Prostaglandin Alone n = 44
Value	.78 (.63)	-.03 (.39)

Trusopt vs Prostaglandin Alone: p = .6081, ANCOVA

Primary outcome: 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: unitless

Measure	Trusopt n = 12	Prostaglandin Alone n = 44
Value	-.011 (.020)	.002 (.008)

Trusopt vs Prostaglandin Alone: p = .1822, ANCOVA

Primary outcome: 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Trusopt n = 12	Prostaglandin Alone n = 44
Value	0.24 (.34)	-.045 (.15)

Trusopt vs Prostaglandin Alone: p = .2383, ANCOVA

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glaucoma Patients	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Small numbers of participants at various time-points limited the power of analysis in our estimation, as did patients who changed medications and therefore further limited analysis options at various time-points.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Alon Harris, PhD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Indiana University 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 11 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 22 Jan 2014. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) (time frame: Baseline and 6 month visits). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145898.

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 22 Jan 2014.