Clinical Trial: Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 di
Sponsor: The Catholic University of Korea

Current Primary Outcome:

• Intraocular Pressure (IOP), Period 1 [ Time Frame: 4 weeks ]
  IOP (mean IOP) after 4 weeks of treatment
• Intraocular Pressure (IOP), Period 2 [ Time Frame: 12 weeks ]
  IOP (mean IOP) after treaemt from week 8 to week 12
• Blood Pressure (BP), Period 1 [ Time Frame: 4 weeks ]
  systolic and diastolic BP at 4 weeks after use of eyedrops
• Blood Pressure (BP), Period 2 [ Time Frame: 12 weeks ]
  systolic and diastolic BP measured after treaemt from week 8 to week 12

Original Primary Outcome:

• Intraocular Pressure (IOP) [ Time Frame: 4 weeks ]
  IOP (mean IOP, peak IOP, trough IOP), diastolic and systolic BP
• IOP [ Time Frame: 12 weeks ]
  IOP (mean IOP, peak IOP, trough IOP), diastolic and systolic BP
• Blood Pressure (BP) [ Time Frame: 4 weeks ]
  systolic and diastolic BP
• BP [ Time Frame: 12 weeks ]
  systolic and diastolic BP

Current Secondary Outcome:

• Ocular Perfusion Pressure (OPP), Period 1 [ Time Frame: 4 weeks ]

  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, Period 2 [ Time Frame: 12 weeks ]

  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 after treaemt from week 8 to week 12

Original Secondary Outcome:

• Ocular Perfusion Pressure (OPP) [ Time Frame: 4 weeks ]

  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 ]

  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

Information By: The Catholic University of Korea

Dates:
Date Received: July 26, 2010
Date Started: March 2011
Date Completion:
Last Updated: December 12, 2014
Last Verified: December 2014