N/A
N=44
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Normal Tension Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01175902 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Intraocular Pressure (IOP), Period 1 — 13.72; 13.50; 13.27; 13.36 mmHg — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dorzolamide/timolol (Drug); latanoprost (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- The Catholic University of Korea
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP), Period 1 |
13.72; 13.50; 13.27; 13.36; 13.54; 12.63 | 0.05 |
| PRIMARY Intraocular Pressure (IOP), Period 2 |
13.13; 12.36; 12.81; 12.36; 12.54; 12.72 | — |
| PRIMARY Blood Pressure (BP), Period 1 |
121.82; 122.82; 120.68; 119.14; 120.45; 120.55 | — |
| PRIMARY Blood Pressure (BP), Period 2 |
123.14; 118.41; 123.59; 117.95; 122.41; 119.05 | — |
| SECONDARY Ocular Perfusion Pressure (OPP), Period 1 |
46.57; 49.12; 46.65; 46.95; 46.21; 48.17 | — |
| SECONDARY OPP, Period 2 |
48.36; 46.71; 48.04; 46.07; 48.47; 45.90 | — |
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.
Eligibility 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
- age ranging from 45 to 75 years
- best-corrected visual acuity no worse than 20/30 Snellen equivalent
- 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
- 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)
- repeated measurements of untreated IOP, which documented values less than 22 mmHg
- central corneal thickness ranging from 540 to 560 microns
- open-angle confirmed by gonioscopy
Exclusion criteria
- active or chronic systemic diseases and/or concomitant assumption of any medication known to affect IOP, BP and/or HR
- corneal abnormalities preventing reliable applanation tonometry
- severe ocular trauma, ocular inflammation or infection, intraocular surgery or argon laser treatment or laser trabeculoplasty
- myopic or other fundus changes preventing reliable optic disc evaluation,
- visual field defects caused by nonglaucomatous disease
- history of allergy to the ingredients of Cosopt or Xalatan eye drops
Data sourced from ClinicalTrials.gov (NCT01175902). 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.