Dataset Information

Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.

ABSTRACT: Purpose:To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye. Methods:A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity. Results:A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was -16.9±17.5 for CMC-HA and -16.0±16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved (P<0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC (P=0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity. Conclusion:The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.

SUBMITTER: Aragona P

PROVIDER: S-EPMC7534849 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.

Aragona Pasquale P Benítez-Del-Castillo Jose M JM Coroneo Minas T MT Mukherji Subhanjan S Tan Jacqueline J Vandewalle Evelien E Vingrys Algis A Liu Haixia H Carlisle-Wilcox Cindy C Vehige Joseph J Simmons Peter A PA

Clinical ophthalmology (Auckland, N.Z.) 20201001

<h4>Purpose</h4>To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.<h4>Methods</h4>A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with foll ...[more]

PMID: 33061281

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Project description:BackgroundFor patients who experience dry eye after phacoemulsification, vision and quality of life can significantly deteriorate. In this study, the efficacy and safety of carboxymethylcellulose sodium (CMC) 1% ophthalmic solution combined with conventional therapy in treating dry eye signs and symptoms after phacoemulsification were evaluated.MethodsIn this prospective, multicenter, open-label, controlled study, 180 patients with age-related cataract were randomized to treatment with conventional therapy plus CMC 1% (n = 90) or to conventional therapy only (control group, n = 90) after phacoemulsification and intraocular lens implantation. Tear breakup time (TBUT), the Schirmer test with anesthesia, and fluorescein and lissamine green staining were performed. The Ocular Surface Disease Index (OSDI) questionnaire and a patient subjective symptom evaluation were administered preoperatively (baseline) and postoperatively at 7 and 30 days.ResultsTBUT was significantly longer in the treatment group compared with the control group at day 7 (8.5 ± 5.5 versus 6.6 ± 3.8 s; P = 0.0475) and day 30 (9.0 ± 5.9 versus 6.7 ± 4.8 s; P = 0.0258) after surgery. Compared with baseline, TBUT significantly increased in patients in the treatment group (P < 0.001 at both day 7 and day 30) with a presurgical diagnosis of dry eye, but significantly decreased in patients in the control group (P < 0.02 at both day 7 and day 30) with no prior diagnosis of dry eye. Fluorescein and lissamine staining, OSDI questionnaire and subjective symptom scores all improved from baseline, with no significant differences between the two groups. No significant differences in tolerability and safety were observed between the group receiving CMC and conventional therapy, and those receiving conventional therapy only.ConclusionTreatment with CMC 1% can provide significant improvement in tear film stability after phacoemulsification for age-related cataract.Trial registrationClinicalTrials.gov identifier NCT02028754 (Date of registration: Jan. 6, 2014).

Dataset Information

Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.

Publications

Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.

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