INTRODUCTION: Dry eye is a multifactorial condition of the eye caused by insufficient tear production and imbalance in tear composition leading to faster evaporation of tear fluid. It is also associated with inflammation that often leads to ocular surface damage. Symptoms of dry eyes include itchiness, soreness, red eyes, a burning sensation, eye fatigue and blurred vision. The objective of this study was to evaluate the efficacy and safety of our multi-ingredient supplement in subjects with dry eye syndrome (DES). METHODS: We recruited 60 subjects with mild to moderate DES who were randomized in a 1:1 ratio in a single-center study to receive LCD (lutein 20 mg, zeaxanthin 4 mg, curcumin 200 mg curcuminoids, vitamin D3 600 IU) or placebo (soybean oil) capsules for 8 weeks. The primary outcomes evaluated were changes in tear volume by Schirmer's test and ocular symptoms by the Ocular Surface Disease Index (OSDI); secondary outcomes included evaluation of changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break-up time (TBUT), corneal and conjunctival staining, tear osmolarity, matrix metalloproteinase-9 (MMP-9), artificial tear use and safety assessments. The outcomes were compared between the LCD and placebo groups at baseline and day 56 of supplementation. RESULTS:Fifty-nine subjects, 30 from LCD and 29 fromplacebo group, completed the study. The LCD group showed significant improvements (P < 0.0001) for Schirmer's test, OSDI, TBUT, SPEED, ocular staining scores, tear osmolarity (P = 0.0005), MMP-9 (P = 0.0017) and reduced artificial tear use (P = 0.0004) and its frequency of use (P < 0.0001) in subjects compared to placebo from baseline to day 56. No safety issues were observed in the study. CONCLUSION: The LCD supplement showed significant improvements in the production, stability and quality of tears by reducing ocular surface damage and tear inflammation and can be used as an adjuvant to artificial tears in subjects with DES. TRIAL REGISTRATION: Clinical Trials Registry of India (http://ctri.nic.in/) identifier: CTRI/2021/01/030493.
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INTRODUCTION:Dry eye is a multifactorial condition of the eye caused by insufficient tear production and imbalance in tear composition leading to faster evaporation of tear fluid. It is also associated with inflammation that often leads to ocular surface damage. Symptoms of dry eyes include itchiness, soreness, red eyes, a burning sensation, eye fatigue and blurred vision. The objective of this study was to evaluate the efficacy and safety of our multi-ingredient supplement in subjects with dry eye syndrome (DES). METHODS: We recruited 60 subjects with mild to moderate DES who were randomized in a 1:1 ratio in a single-center study to receive LCD (lutein 20 mg, zeaxanthin 4 mg, curcumin 200 mg curcuminoids, vitamin D3 600 IU) or placebo (soybeanoil) capsules for 8 weeks. The primary outcomes evaluated were changes in tear volume by Schirmer's test and ocular symptoms by the Ocular Surface Disease Index (OSDI); secondary outcomes included evaluation of changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break-up time (TBUT), corneal and conjunctival staining, tear osmolarity, matrix metalloproteinase-9 (MMP-9), artificial tear use and safety assessments. The outcomes were compared between the LCD and placebo groups at baseline and day 56 of supplementation. RESULTS: Fifty-nine subjects, 30 from LCD and 29 from placebo group, completed the study. The LCD group showed significant improvements (P < 0.0001) for Schirmer's test, OSDI, TBUT, SPEED, ocular staining scores, tear osmolarity (P = 0.0005), MMP-9 (P = 0.0017) and reduced artificial tear use (P = 0.0004) and its frequency of use (P < 0.0001) in subjects compared to placebo from baseline to day 56. No safety issues were observed in the study. CONCLUSION: The LCD supplement showed significant improvements in the production, stability and quality of tears by reducing ocular surface damage and tear inflammation and can be used as an adjuvant to artificial tears in subjects with DES. TRIAL REGISTRATION: Clinical Trials Registry of India (http://ctri.nic.in/) identifier: CTRI/2021/01/030493.
Authors: Javier Ávila-Román; Sara García-Gil; Azahara Rodríguez-Luna; Virginia Motilva; Elena Talero Journal: Mar Drugs Date: 2021-09-23 Impact factor: 5.118