In-SIGHT study v2 24 May 2018
Research type
Research Study
Full title
Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.
IRAS ID
218623
Contact name
Aude BARDIOT
Contact email
Sponsor organisation
Laboratoires THEA
Eudract number
2017-000846-23
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Research Summary
This study is proposed to patients presenting a glaucoma or an ocular hypertension, also called high eye pressure.
The aim of this study is to show:
- how well T4032 eye drops work in lowering the high eye pressure and
- how safe they are, compared to another product, called Lumigan®.
Lumigan® is already used by patients with glaucoma or with high eye pressure. It is a sterile solution containing bimatoprost 0.01%, presented in bottle.
T4032 is a new eye-drop treatment developed by Laboratoires THÉA. It is a sterile ophthalmic gel containing bimatoprost 0.01%, presented in unit doses.
T4032 unit doses contain the same product as the Lumigan bottle (bimatoprost), except that they do not contain any preservatives. The preservatives in glaucoma medication can cause irritation to the surface of the eye.
By producing a drop without preservatives, Laboratoires THÉA hope to improve how well the treatment is tolerated and continue to lower the high eye pressure.
Laboratoires Théa have decided to perform a phase III clinical study in order to investigate the efficacy and safety of this newly proposed unpreserved gel formulation of bimatoprost 0.01% (T4032), administered once daily for 12 weeks, in OHT and glaucoma patients.
This study aims at demonstrating the non-inferiority of the unpreserved T4032 to BAK- preserved Lumigan® 0.01% for the reduction of IOP in a well-defined and homogeneous population of OHT and open-angle glaucoma patients initially treated and controlled for at least 6 months by any prostaglandin monotherapy.
In this study it is planned to enroll 434 patients and to randomize 400 patients in order to have 360 evaluable patients.Summary of Results
This study demonstrated that T4032 was non-inferior to Lumigan in ocular hypertensive or glaucomatous patients with respect to change in Intraocular pressure (mmHg) from baseline at Week 12 in the worse eye with a predefined non-inferiority margin of 1.5 mmHg. Furthermore, local tolerability appeared to be better for T4032 than for Lumigan.REC name
HSC REC B
REC reference
18/NI/0129
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion