Clinical outcomes Following Treatment with SYSTANE® BALANCE
Research type
Research Study
Full title
Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects with Lipid-Deficient Dry Eye (United Kingdom only)
IRAS ID
229833
Contact name
Ali Mearza
Sponsor organisation
Alcon Research Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
The tear film is a thin layer of moisture on the eye composed of a fatty layer (exposed to the air), a viscous (gooey) layer next to the eye and a thicker watery layer in the middle. Lipid deficient dry eye means that there is less of the fatty layer in the tear film. As a result, the watery layer evaporates quicker and the cells on the cornea become exposed to the air which causes the burning, stinging, and redness, itchiness or swelling symptoms. Lubricating eye drops try to replenish the fatty and watery layers of the tear film so the cells on the cornea have less exposure to air. \nSYSTANE BALANCE is a lipid-based artificial tear drop and has been formulated with a\npatented Lipitech™ system (consisting of phospholipids and mineral oil) to help address dry eye signs and symptoms caused by a deficiency in the lipid layer of the tear film. A new addition to the lipid-based subgroup of artificial tear products (OPTIVE Plus) contains castor oil. Currently there are no data comparing the effectiveness of both products, supplementing the lipid layer of patients with lipid-deficient dry eye.\nThe purpose of this study is to evaluate the clinical effectiveness of SYSTANE BALANCE compared to OPTIVE Plus in patients with dry eye associated with lipid deficiency.\nApproximately 220 people will take part in this prospective, double-masked, randomized, parallel-group study across multiple sites in the United States (US), Australia, Singapore, Taiwan and UK. The study in UK will involve up to 50 participants, four clinic visits over 49 days period. Participant will use either SYSTANE BALANCE or OPTIVE Plus four times a day over 35 days.\n\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0159
Date of REC Opinion
13 Sep 2017
REC opinion
Further Information Favourable Opinion