Effectiveness of GANfort® in reducing intraocular pressure in patients presenting with significantly elevated intraocular pressure

• Conditions: Primary Open Angle GlaucomaOcular Hypertension; MedDRA version: 9.1Level: PTClassification code 10022806Term: Intraocular pressure increased

• Registration Number: EUCTR2007-001046-41-GB
• Lead Sponsor: ottingham University Hospital NHS Trust (Research & Development)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified