Evaluation of Clinical Outcomes after the use of SYSTANE HYDRATION
Research type
Research Study
Full title
Evaluation of Clinical Outcomes Following the use of SYSTANE HYDRATION in Subjects with Dry Eye
IRAS ID
181562
Contact name
Jennifer Forbes
Contact email
Sponsor organisation
Alcon Research Ltd
Clinicaltrials.gov Identifier
A02041, Sponsor's Project number
Duration of Study in the UK
1 years, 2 months, 17 days
Research summary
Dry eye disease (DED) or dry eye syndrome is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface, which often adversely impacts the quality of life as well as occupational productivity leading to a deteriation in work performance. The eye drops soothe and lubricate the surface of the eyes. It acts as artificial tears to help ease dryness and soreness associated with dry eye conditions.
Potential benefits of Systane Hydration include improvement in clinical measures related to ocular surface staining, tear film instability, reduction in the need for higher dosing or expensive alternative dry eye therapies, improvement in patient’s quality of life and treatment satisfaction.
The purpose of this research study is to compare Systane Hydration Lubricant Eye Drops to Hyabak 0.15% Lubricant Eye Drops. Both Hyabak and Systane Hydration belong to a class of eye drops to reduce symptoms associated with dry eye disease.
Systane Hydration and Hyabak 0.15% currently have CE Marking and are in commercial distribution within the European Union.
The investigation will use a randomized (1:1) multicenter, parallel-group, double-masked design.
Approximately 100 adult men and women will take part in this research study in approximately four countries in Europe. 2 research sites in the UK will take part in this study and will enroll approximately 10 subjects each. The study enrollment is competitve, the number of enrolled subjects may vary from site to site.
Only 2 research sites (1 in the UK and 1 in France) will perform additional examinations including a digital photography and video of the eyes.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0209
Date of REC Opinion
6 Jul 2015
REC opinion
Further Information Favourable Opinion