Christopher Lievens 1 , Gregg Berdy 2 , David Douglass 3 , Stephen Montaquila 4 , Hugh Lin 5 , Peter Simmons 6 , Cindy Carlisle-Wilcox 7 , Joseph Vehige 8 , Sameena Haque 9 Show Affiliations »
Abstract
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PURPOSE: In a randomized, controlled clinical trial, two lubricant artificial tear formulations with enhanced viscosity were compared: an investigational product at the time, containing carboxymethylcellulose 1.0% and glycerin 0.9% (CMC-GLY) with osmoprotectants, and a standard formula containing carboxymethylcellulose 1.0% alone (CMC ). METHODS: This double-masked study recruited patients with moderate to severe dry eye at 10 US centers . After a 7-day run-in with CMC 0.5% (Refresh Tears) patients were randomized to use either CMC-GLY or CMC as needed, but at least 2 times daily for 30 days. Patients were stratified by Ocular Surface Disease Index© (OSDI) score into moderate (23-32) and severe (> 32-65) subgroups. Assessments included OSDI (primary efficacy variable), corneal and conjunctival staining, tear break-up time (TBUT), symptom surveys, and safety variables . Study visits were days 1 (baseline/randomization), 7, and 30. RESULTS: A total of 188 patients (94 CMC-GLY, 94 CMC) were enrolled . The severe subgroup had 67 CMC-GLY and 65 CMC patients. OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p < 0.001, severe p < 0.001), corneal staining (p = 0.004), and TBUT (p < 0.001). Between-group dose frequency for CMC-GLY was lower at day 7 (p = 0.031). Other efficacy results were similar between groups. The most commonly reported adverse event in both groups was blurred vision. CONCLUSIONS: Overall, the CMC-GLY artificial tear formulation was as effective as the CMC formulation. CMC-GLY demonstrated improvements at an earlier stage (day 7). Both artificial tear formulations were safe and well tolerated , with no treatment-related serious adverse events. These results support the use of the CMC-GLY artificial tear formulation as an effective treatment to reduce the symptoms and signs of dry eye disease.
RCT Entities: Population
Interventions
Outcomes
PURPOSE: In a randomized, controlled clinical trial, two lubricant artificial tear formulations with enhanced viscosity were compared: an investigational product at the time, containing carboxymethylcellulose 1.0% and glycerin 0.9% (CMC-GLY ) with osmoprotectants , and a standard formula containing carboxymethylcellulose 1.0% alone (CMC ). METHODS: This double-masked study recruited patients with moderate to severe dry eye at 10 US centers. After a 7-day run-in with CMC 0.5% (Refresh Tears) patients were randomized to use either CMC-GLY or CMC as needed, but at least 2 times daily for 30 days. Patients were stratified by Ocular Surface Disease Index© (OSDI) score into moderate (23-32) and severe (> 32-65) subgroups. Assessments included OSDI (primary efficacy variable), corneal and conjunctival staining, tear break-up time (TBUT ), symptom surveys, and safety variables. Study visits were days 1 (baseline/randomization), 7, and 30. RESULTS: A total of 188 patients (94 CMC-GLY , 94 CMC ) were enrolled. The severe subgroup had 67 CMC-GLY and 65 CMC patients . OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p < 0.001, severe p < 0.001), corneal staining (p = 0.004), and TBUT (p < 0.001). Between-group dose frequency for CMC-GLY was lower at day 7 (p = 0.031). Other efficacy results were similar between groups. The most commonly reported adverse event in both groups was blurred vision . CONCLUSIONS: Overall, the CMC-GLY artificial tear formulation was as effective as the CMC formulation. CMC-GLY demonstrated improvements at an earlier stage (day 7). Both artificial tear formulations were safe and well tolerated, with no treatment-related serious adverse events. These results support the use of the CMC-GLY artificial tear formulation as an effective treatment to reduce the symptoms and signs of dry eye disease .
Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
Entities: Chemical
Disease
Species
Keywords:
Artificial tear; Carboxymethylcellulose; Dry eye; Glycerin; Lubricant eye drop; Viscosity
Year: 2018
PMID： 30573298 DOI： 10.1016/j.clae.2018.12.003
Source DB: PubMed Journal: Cont Lens Anterior Eye ISSN： 1367-0484 Impact factor: 3.077