Glaucoma
Conditions
Interventions
Product Name: Ibopamine 2%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Ibopamine HCL
CAS Number: 66195-31-1
Other descriptive name: Trazyl 2%
Concentration unit: % percent
Concentrat
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included if they have primary open angle glaucoma as defined by: characteristic and corresponding visual field and optic disc findings which are consistent with glaucoma and an intraocular pressure on treatment of at least 20% less than that prior to treatment. Progression is based on a worsening of visual field loss on at least three consecutive visual field tests performed over at least the preceding 12 months. Stability is based on a stable visual field on at least three consecutive visual field tests performed over at least the preceding 12 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will include: those with secondary glaucoma, those who have undergone previous intraocular surgery (except cataract surgery), those who were unable to perform a reliable visual field test, those who were unable to give informed consent, those who cannot lie flat and those who have conditions which will elevate superior vena caval pressure (e.g chronic obstructive airways disease, congestive heart failure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do patients with progressively worsening glaucoma, despite appropriate treatment, exhibit a rise in intraocular pressure when they lie down; and can these same patients be identified by the topical application of a single dose of Ibopamine in the clinic.;Secondary Objective: Are there other factors which might differentiate these two groups: e.g optic nerve appearance, change in optic nerve appearance after the use of Ibopamine. ;Primary end point(s): The proportion who of patients who exhibit a rise in intraocular pressure of greater than 3 mmHg following either lying down, or the topical application of Ibopamine. | — |
Countries
United Kingdom
Outcome results
None listed