Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Condition: Normal Tension Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Study type: Interventional

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 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)
    

Intervention name(s): dorzolamide/timolol; latanoprost
Intervention type(s): Drug; Drug
Intervention description(s): dorzolamide/timolol fixed combination eyedrop, 2 times a day; compare with dorzolamide/timolol fixed combination eyedrop one time a day
Other intervention name(s): Cosopt; Xalatan
Intervention MeSH terms: Timolol; Dorzolamide; Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Normal tension glaucoma