Efficacy & tolerability of SYSTANE® Complete with dry eye subjects
Research type
Research Study
Full title
Evaluation of the Clinical Efficacy and Tolerability of SYSTANE® Complete in Adult Patients with Dry Eye Disease following Topical Ocular use for 4 Weeks: A Multicenter Trial.
IRAS ID
253772
Contact name
Ali Mearza
Contact email
Sponsor organisation
Alcon Research, Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 28 days
Research summary
The use of artificial tear products (ATPs)to replace and/or supplement the deficient natural tear film, is the main option in dry eye disease. Selection of the appropriate tear substitute to address a patient’s tear deficiency can become a ‘trial and error’, for general eye care practitioners who do not have the appropriate support to evaluate the underlying cause of their patient’s dry eye symptoms.
SYSTANE® Complete is a tear film ocular lubricant used to replenish deficiencies in the natural tear film for temporary relief of dry eye symptoms. In combination with a higher amount of gelling technology and a lipid excipient in smaller nano-sized droplets to optimize the lipid surface coverage and make the emulsion formulation less opaque (i.e. translucent), this formulation has the potential to restore deficiencies in both the aqueous and lipid layers of the tear film which would simplify the selection process of the appropriate ATP for patient’s dry eye symptoms.
The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye. This study will evaluate improvement in tear film integrity, symptoms, tolerability, corneal integrity. This is a phase IV, multicenter, open label, single-arm, interventional study involving 134 subjects for 28 days. There will be 4 study visits.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0456
Date of REC Opinion
3 Dec 2018
REC opinion
Further Information Favourable Opinion