The Effects of Cosopt® Vs Xalacom® on Ocular Hemodynamics and Intraocular Pressure (IOP) in Primary Open-angle Glaucoma (POAG)

NCT00815373 | Withdrawn DMC

• 1 other identifier: 0155-08-MMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Both Cosopt® and Xalatan® plus Timoptic® will significantly lower IOP, however only Cosopt® will demonstrate positive hemodynamic effects. The clinical significance of this will be investigated by examining the ophthalmic and short posterior ciliary arteries to determine the blood supply to the optic nerve head, the site of damage in glaucoma

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Ocular Blood flow; Ocular hypertension; POAG; Ocular hemodynamics; Xalacom; Cosopt

Outcome Measures

Primary Outcomes (1)

• Ocular hemodynamics as measured by Color Doppler imaging

  3 years

Secondary Outcomes (1)

• Intraocular pressure as measured by Goldmann applanation tonometry

  3 Years

Study Arms (2)

1

ACTIVE COMPARATOR

Cosopt\* b. i. d. (dosed morning and bedtime) will be administered topically

Drug: Dorzolamide+Timolol Maleate0.5%

2

ACTIVE COMPARATOR

Xalacom\* q.d.(dosed bedtime) and placebo vehicle q.d. (dosed morning) topically in the other group

Drug: Latanoprost+Timolol Maleate0.5%+Lytears

Interventions

Dorzolamide+Timolol Maleate0.5% DRUG

Cosopt\* b. i. d.

Also known as: Cosopt

1

Latanoprost+Timolol Maleate0.5%+Lytears DRUG

Xalacom\* QHS

Also known as: Xalacom* QHS

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or greater.
• Patient signed an informed consent agreement.
• Corrected visual acuity of 6/12 or better:
• Characteristic glaucomatous visual-field loss and optic nerve head damage in one or both eyes.
• Either IOP measurements ≥21 mmHg in the 3 months prior to study entry or IOP ≥ 21 mmHg at the end of the washout period
• Patient on ≥1 IOP reducing agents. -

You may not qualify if:

• Past history of ocular diseases (other than OAG / Cataract / Refractive error).
• Past history of orbital/ocular surgery or trauma.
• Receiving ≥ 3 IOP reducing agents.
• Receiving agents known to produce significant cardiovascular, respiratory, renal or hepatic side effects.
• Personal history of respiratory disease such as asthma, emphysema or other chronic obstructive pulmonary disease.
• Personal history of congestive heart failure.
• Personal history of bradycardia or 2nd and 3rd degree AV block.
• Known allergy to sulfa.
• Women who are pregnant or nursing.
• Women who of child bearing age who are planning to become pregnant within one month after study completion.
• Receiving Levitra, Viagra, Cialis or other erectile dysfunction drugs.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Adi Abulafia, MD

  Meir Medical Center, Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 30, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

IL (1)