Primary Open Angle Glaucoma Ocular Hypertension MedDRA version: 9.1 Level: PT Classification code 10022806 Term: Intraocular pressure increased
Conditions
Interventions
Trade Name: GANfort
Product Name: GANfort
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: bimatoprost
CAS Number: CAS 155206-0
Other descriptive name: BIMATOPROST
Concentration unit: % (
Sponsors
Nottingham University Hospital NHS Trust (Research & Development)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed open angle glaucoma (OAG) or ocular hypertension(OHT) patients with IOPs ³ 25mmHg at presentation and on baseline assessment. 2. OAG and OHT patients presently treated for their raised IOP and willing to undergo a washout period of no medication prior to starting GANfort® 3. No contraindications to any of components of GANfort® 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: 1.1. Unwilling to sign informed consent 2. Patients in whom Beta blockers are contraindicated 3. Patient with a history of severe cardiac disease or overt cardiac failure 4. Sinus Bradycardia, second or third degree Atrioventricular blockPatient with severe asthma, bronchospasm or COAD 5. Paediatric age group 6. Known hypersensitivity to any of the drug ingredients 7. Ocular condition that are of safety concern and that can interfere with the study results 8. Patients with macular oedema 9. Patients with neovascular glaucoma or angle closure glaucoma 10. Closed or narrow anterior chamber angles or history of acute angle closure. 11. Ocular surgery or argon laser trabeculoplasty within the last three months. 12. Ocular inflammation/infection occurring within three months prior to pre-trial visit. 13. Concominant topical ocular medication that can interfere with study medication 14. Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement. 15. Refractive surgery patients at any time 16. Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing. 17. Inability to adhere to treatment/visit plan. 18. Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the extent to which GANfort®can reduce IOP in patients presenting with significantly elevated IOP at the 10 am IOP measurement.. 2. To determine the diurnal IOP control achieved with GANfort® ;Secondary Objective: 1. Local and systemic side effect profile of medications 2. To determine the effectiveness of a uniocular drug trial in prediction of IOP lowering in the second treated eye with GANfort® when both the eyes require treatment(9, 10). ;Primary end point(s): The primary endpoint is IOP lowering at 3 months | — |
Countries
United Kingdom
Outcome results
None listed