Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To prove the non-inferiority of the fixed timolol-dorzolamide combination (Cosopt) compared to 0.005% latanoprost (Xalatan) in the aspects of intraocular pressure (IOP) and ocular perfusion pressure (OPP) in subjects with normal tension glaucoma (NTG)

Clinical hypotheses. Primary hypothesis

• Cosopt group is non-inferior to Xalatan group in diurnal IOP reduction.

Secondary hypothesis

• Cosopt group is non-inferior to Xalatan group in diurnal diastolic and systolic OPP.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborator: Seoul St. Mary's Hospital
• Treatments: Dorzolamide; Latanoprost; Ophthalmic Solutions; Tetrahydrozoline; Timolol

Criteria

The identification of NTG was based on reproducible glaucomatous visual field defects, corresponding to typical ONH changes.

Unilateral or bilateral visual field loss (description as below) as determined by at least two consecutive automated static threshold perimetry tests.

One eye is randomly selected in the cases where both eyes are treated.

Inclusion criteria:

1. age ranging from 45 to 75 years

2. best-corrected visual acuity no worse than 20/30 Snellen equivalent

3. optic nerve head cupping (i.e., a vertical cup-to-disc ratio of more than 0.6) and/or notching of neuroretinal rim, and/or retinal nerve fiber defects characteristic of glaucoma

4. visual field loss (i.e., a localized defect with at least three adjacent nonedge points depressed >5 dB from the normal value, and a nucleus of at least one point depressed 10 dB from the normal value)

5. repeated measurements of untreated IOP, which documented values less than 22 mmHg

6. central corneal thickness ranging from 540 to 560 microns

7. open-angle confirmed by gonioscopy

Exclusion criteria:

1. active or chronic systemic diseases and/or concomitant assumption of any medication known to affect IOP, BP and/or HR

2. corneal abnormalities preventing reliable applanation tonometry

3. severe ocular trauma, ocular inflammation or infection, intraocular surgery or argon laser treatment or laser trabeculoplasty

4. myopic or other fundus changes preventing reliable optic disc evaluation,

5. visual field defects caused by nonglaucomatous disease

6. history of allergy to the ingredients of Cosopt or Xalatan eye drops