N/A N=56

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

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT01145898 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jan 2014

Primary outcome: Primary: 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) — 2.32; -.30 cm/sec — p=.6261

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: (Cosopt®, prostaglandin) (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)	2.32; -.30	.6261
PRIMARY 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)	.78; -.03	.6081
PRIMARY 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)	-.011; .002	.1822
PRIMARY 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)	0.24; -.045	.2383
PRIMARY 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)	.18; -.12	.2383
PRIMARY 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)	-.012; .005	.1564
PRIMARY 6-month Change in Ocular Perfusion Pressures (OPP)	-.30; -2.88	.2265
PRIMARY 3-year Change in OA PSV	-.62; .07	.4645
PRIMARY 3-year Change in OA EDV	-.58; -.98	.5998
PRIMARY 3-year Change in OA RI	.042; .036	.8119
PRIMARY 3-year Change in CRA PSV	-.66; .37	.1319
PRIMARY 3-year Change in CRA EDV	-.21; .12	.0199 sig
PRIMARY 3-year Change in CRA RI	.007; .013	.7597
PRIMARY 3-year Change in OPP	-4.91; -1.43	.2528

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01145898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.