Abstract
Objectives
Dry eye is a chronic condition associated with insufficient tear production and faster tear evaporation and commonly accompanied by inflammation that may lead to ocular surface damage. We have developed a multi-ingredient formulation containing lutein, zeaxanthin, curcumin, and vitamin D3 to address conditions associated with dry eye. The objective of this study was to evaluate the efficacy and safety of our formulation in subjects with mild to moderate dry eye symptoms.
Methods
This was a randomized, double-blind, parallel, placebo-controlled study. Sixty subjects with mild to moderate DES were randomly assigned in a 1 : 1 ratio to the test or placebo groups. Subjects consumed one capsule of the test or placebo product every morning
through the study duration of 56 days. The test product comprised 20 mg lutein, 4 mg zeaxanthin, 200 mg curcuminoids, and 600 IU vitamin D3 in form of a capsule. The placebo product contained soybean oil. Changes in tear volume by Schirmer's test and severity of dry eye discomfort measured by Ocular Surface Disease Index (OSDI) score, changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break up time (TBUT), corneal & conjunctival staining, tear osmolarity, Matrix Metalloproteinases (MMP)-9 levels in tear fluid, and artificial tear usage were evaluated.
Results
Thirty subjects in Test and 29 in Placebo group completed study. We observed statistically significant (P < 0.05) improvements in tear volume, TBUT, and a reduction in dry eye discomfort as measured by OSDI and SPEED scores from baseline to day 56 in the Test group. Mean corneal & conjunctival staining scores, tear osmolarity and tear MMP-9 levels also showed significant improvements (P < 0.05) when compared to Placebo on day 56. Artificial tear usage & frequency of usage were significantly reduced (P < 0.05) in test group as compared to Placebo. Products were well tolerated without any adverse events.
Conclusions
Our multi-ingredient formulation demonstrated significant improvement in dry eye conditions including eye hydration and moisture, tear stability and quality, and overall improvements in eye comfort.
Funding Sources
OmniActive Health Technologies
Effect of 0.3% Hydroxypropyl Methylcellulose/Dextran Versus 0.18% Sodium Hyaluronate in the Treatment of Ocular Surface Disease in Glaucoma Patients: A Randomized, Double-Blind, and Controlled Study
