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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by The Catholic University of Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul St. Mary's Hospital
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01175902
First received: July 26, 2010
Last updated: April 15, 2011
Last verified: May 2010
  Purpose

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.

Condition Intervention
Normal Tension Glaucoma
Drug: dorzolamide/timolol fixed combination
Drug: latanoprost

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Prove the Non-inferiority of Cosopt Compared to Xalatan in the Aspects of Intraocular Pressure and Ocular Perfusion Pressure in Subjects With Normal Tension Glaucoma

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    IOP (mean IOP, peak IOP, trough IOP), diastolic and systolic BP

  • IOP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    IOP (mean IOP, peak IOP, trough IOP), diastolic and systolic BP

  • Blood Pressure (BP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    systolic and diastolic BP

  • BP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    systolic and diastolic BP


Secondary Outcome Measures:
  • Ocular Perfusion Pressure (OPP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    OPP was calculated according to the following formula:

    OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP


  • OPP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    OPP was calculated according to the following formula:

    OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP



Estimated Enrollment: 44
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xalatan
Patients on Xalatan eyedrops
Drug: latanoprost
compare with Cosopt one time a day
Other Name: Xalatan
Experimental: Cosopt Drug: dorzolamide/timolol fixed combination
Cosopt eyedrop, 2 times a day
Other Name: Cosopt

Detailed Description:

Cosopt (dorzolamide/timolol fixed combination) has well known effect for IOP reduction in POAG and OHT.3-5 However, there is no study about the effect and safety of Cosopt in NTG, Cosopt is not used the first line drug in the management of NTG.

In Korea, the prevalence of NTG is higher than western countries, the majority (about 80-90%) of open angle glaucoma patients have an IOP of 21 mmHg or less, so the study of NTG is important and searching of effective drug for the treatment of NTG is necessary.

In this study, we would prove the non-inferiority of Cosopt compared to Xalatan,6 which is used as a first line drug in the management of NTG, in the aspects of IOP and OPP including diastolic OPP (DOPP).

A prospective, interventional, randomized, crossover, single masked, single center study. Forty-four NTG patients were randomly allocated to one of two groups. Patients in group A were treated with Cosopt, lubricant, and Xalatan for 4 weeks each, whereas patients in group B were treated with Xalatan, lubricant, and Cosopt for 4 weeks each.

Recruit NTG patients, who are not treated with the glaucoma medication recent 2 months. If treated, after washout period of 4 weeks, the patients can be included in the study. Baseline IOP, systolic and diastolic BP will be measured. (Day 1) After 4 weeks of treatment of Cosopt or Xalatan, all participants will be checked diurnal IOP, systolic and diastolic BP. IOP was measured by Goldmann applanation tonometry (mean of three consecutive readings) with the patient in a sitting position at the slit lamp. Every IOP will be measured by one masked glaucoma specialist who is unaware of the treatment assignments. After the IOP measurements, after a 5-minite rest, pulse rate and BP (systolic and diastolic) of radial artery were measured in the sitting position using a standard automated blood pressure cuff. During the period, all measuring instruments keep to be calibrated by the manufacturer's instruction.

- OPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP. During the 4 weeks washout period, subjects will use lubricants.(Week 8) In this crossover study, with the other eye drops, the same measurement will be performed. (Week 12)

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175902

Contacts
Contact: Chan Kee Park, M.D., PhD. 82222586199 ckpark@catholic.ac.kr
Contact: Na Young Lee, M.D., PhD. nayoung55@naver.com

Locations
Korea, Republic of
Seoul St. Mary's hospital Recruiting
Seoul, Korea, Republic of, 137-070
Contact: Hae Young L Park, M.D.    82222586342    lopilly@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea
Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Department of ophthalmology and visual science, College of medicine
ClinicalTrials.gov Identifier: NCT01175902     History of Changes
Other Study ID Numbers: cosopt-IOP/OPP
Study First Received: July 26, 2010
Last Updated: April 15, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by The Catholic University of Korea:
Normal tension glaucoma

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Timolol
Latanoprost
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014