Obs study of tafluprost/timolol in glaucoma or ocular hypertension
Research type
Research Study
Full title
Preservative-free fixed-dose combination of tafluprost 0.0015% / timolol 0.5% in patients with open-angle glaucoma or ocular hypertension: Clinical effectiveness, tolerability and safety in a real world setting
IRAS ID
220487
Contact name
David Broadway
Contact email
Sponsor organisation
Santen GmBH
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
Increased fluid pressure (intraocular pressure) inside the eye is a major risk factor for glaucoma, and therefore should be sustainably lowered in patients with glaucoma or high eye pressure (ocular hypertension). This will reduce it progressing to glaucomatous optic neuropathy or ocular hypertension converting to glaucoma. There are numerous therapies for lowering increased fluid pressure, and in most cases it has been observed that single therapy is not effective at lowering the fluid pressure and most times combination therapy is required.
This is a prospective, non-interventional study of the efficacy, tolerability and safety of Tafluprost / Timolol in adult patients with open angle glaucoma or ocular hypertension who do not sufficiently respond to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops. This combination is preferred as there is better compliance, no danger of confusion of vials and no preservatives.
The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by a mean change in increased fluid pressure from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or high eye pressure who do not respond sufficiently to initial topical treatment, in routine clinical practice. Approximately 1083 patients in 12 countries will take part in the study. This study does not involve any clinical intervention. It will just collect data on up to 6 months of medical history/demographics for each patient.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0246
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion