Abstract
Purpose: :
This was a randomized, investigator-masked, single center, prospective cross-over study looking at dry eye patients’ tolerability of two lipid-containing artificial tears: Refresh Optive Advanced (OA) and Systane Balance (SB).
Methods: :
Forty-six patients with a history of ocular dryness completed the study. Patients were evaluated during four study visits, two for each product (baseline and follow-up after 10 to 17 days of usage), with 7 to 10 days washout before each period. At each visit, questionnaires were administered to ascertain tolerability and product preferences.
Results: :
For tolerability, there was no significant difference between OA and SB. However, there was a trend for subjects to rate OA higher on Clear Vision (73.9±28.1vs 66.9±31.6, p=0.14) and lower on Blur (28.5±30.6 vs 33.4±33.8, p=0.15), and to rate SB lower on Burning and Stinging (16.5±23.5vs 23.1±29.3, p=0.15).The preference questionnaire showed more patients preferred OA compared to SB for overall comfort (OA 43.5%, SB 39.1%, no preference 17.4%), symptom relief (OA 41.3%, SB 32.6%, no preference 26.1%), less burning (OA 41.3%, SB 39.1%, no preference 19.6%) and prefer to purchase (OA 47.8%, SB 34.8%, no preference 17.4%).
Conclusions: :
Both test products demonstrated some benefits to dry eye subjects in this limited clinical evaluation. However, Optive Advanced was preferred overall in the end-of-study questionnaire.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01335126
Keywords: cornea: tears/tear film/dry eye • cornea: clinical science