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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01145898

Enrollment

Registered

2010-06-17

Start date

2010-06-30

Completion date

2012-10-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, Cosopt, blood flow, progression

Brief 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.

Detailed description

Interventions

DRUG(Cosopt®, prostaglandin)

We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age: 30 years or older. 2. Diagnosis: confirmed open-angle glaucoma in at least one eye: 1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry 2. glaucomatous optic disc cupping 3. agreement between two baseline exams for reliability 3. Best corrected visual acuity at least 20/60 in at least one eye. 4. Prior Humphrey visual fields demonstrate acceptable reliability standards.

Exclusion criteria

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields. 2. Evidence of exfoliation or pigment dispersion. 3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. 4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). 5. History or signs of intraocular trauma. 6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment. 7. Any abnormality preventing reliable applanation tonometry. 8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation. 9. Cataract surgery within the past year. 10. Resting pulse \< 50 beats per minute. 11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Design outcomes

Primary

Measure	Time frame	Description
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)	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)	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)	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)	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)	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)	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)	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	Baseline and 36 month visits	Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
3-year Change in OA EDV	Baseline and 36 month visits	Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
3-year Change in OA RI	Baseline and 36 month visits	Measurement of change in ocular blood flow - ophthalmic artery resistance index
3-year Change in CRA PSV	Baseline and 36 month visits	Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
3-year Change in CRA EDV	Baseline and 36 month visits	Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
3-year Change in CRA RI	Baseline and 36 month visits	Measurement of change in ocular blood flow - central retinal arteries resistance index
3-year Change in OPP	Baseline and 36 month visits	Measurement of change in ocular perfusion pressure

Countries

United States

Participant flow

Recruitment details

recruitment over 6 months. Hospital and area eye clinics

Pre-assignment details

observational study, patients were treated by their physician not by study personel, treatments/interventions were self-reported by the patients, treatment was not necessarily started at glaucoma diagnosis

Participants by arm

Arm	Count
Trusopt Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months	12
Prostaglandin Alone Patients with glaucoma taking prostaglandin alone for at least 6 months	44
Total	56

Withdrawals & dropouts

Period	Reason	FG000	FG001
3-year Treatment	medication change by treating physician	3	16

Baseline characteristics

Characteristic	Prostaglandin Alone	Trusopt	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	27 Participants	5 Participants	32 Participants
Age, Categorical Between 18 and 65 years	17 Participants	7 Participants	24 Participants
Age, Continuous	65.25 years STANDARD_DEVIATION 8.78	63.23 years STANDARD_DEVIATION 6.78	64.82 years STANDARD_DEVIATION 8.38
Region of Enrollment United States	44 participants	12 participants	56 participants
Sex: Female, Male Female	31 Participants	5 Participants	36 Participants
Sex: Female, Male Male	13 Participants	7 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

3-year Change in CRA EDV

Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in CRA EDV	-.21 cm/sec	Standard Error 0.21
Prostaglandin Alone	3-year Change in CRA EDV	.12 cm/sec	Standard Error 0.13

p-value: 0.0199ANCOVA

Primary

3-year Change in CRA PSV

Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in CRA PSV	-.66 cm/sec	Standard Error 0.61
Prostaglandin Alone	3-year Change in CRA PSV	.37 cm/sec	Standard Error 0.4

p-value: 0.1319ANCOVA

Primary

3-year Change in CRA RI

Measurement of change in ocular blood flow - central retinal arteries resistance index

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in CRA RI	.007 unitless	Standard Error 0.024
Prostaglandin Alone	3-year Change in CRA RI	.013 unitless	Standard Error 0.014

p-value: 0.7597ANCOVA

Primary

3-year Change in OA EDV

Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in OA EDV	-.58 cm/sec	Standard Error 0.58
Prostaglandin Alone	3-year Change in OA EDV	-.98 cm/sec	Standard Error 0.35

p-value: 0.5998ANCOVA

Primary

3-year Change in OA PSV

Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in OA PSV	-.62 cm/sec	Standard Error 2.41
Prostaglandin Alone	3-year Change in OA PSV	.07 cm/sec	Standard Error 1.25

p-value: 0.4645ANCOVA

Primary

3-year Change in OA RI

Measurement of change in ocular blood flow - ophthalmic artery resistance index

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in OA RI	.042 unitless	Standard Error 0.026
Prostaglandin Alone	3-year Change in OA RI	.036 unitless	Standard Error 0.013

p-value: 0.8119ANCOVA

Primary

3-year Change in OPP

Measurement of change in ocular perfusion pressure

Time frame: Baseline and 36 month visits

Arm	Measure	Value (MEAN)	Dispersion
Trusopt	3-year Change in OPP	-4.91 mm Hg	Standard Error 2.74
Prostaglandin Alone	3-year Change in OPP	-1.43 mm Hg	Standard Error 1.5

p-value: 0.2528ANCOVA

Primary