Efficacy in Patients with Dry Eye After Treatment with a New Lubricant Eye Drop Formulation.
Summary of "Efficacy in Patients with Dry Eye After Treatment with a New Lubricant Eye Drop Formulation."
Abstract Purpose: The effective management of dry eye must include a clinically meaningful reduction in ocular staining. Evaluations of corneal and conjunctival staining and other ocular symptoms of dry eye were conducted for a new formulation of polyethylene glycol 400/propylene glycol-based lubricant eye drops containing hydroxypropyl guar as a gelling agent (Test Product) in comparison to Optive Lubricant Eye Drops (Control Product) in adult patients with dry eye. Methods: One hundred thirteen patients, 18 years of age and older, with dry eye were enrolled in a prospective, double-masked, multisite, parallel-group study. After a 2-week run-in period during which patients administered aqueous saline eye drops 4 times daily (QID) in each eye, patients were randomized (1:1) to receive either Test Product or Control Product to be administered QID for 6 weeks. Efficacy and safety were evaluated by corneal and conjunctival staining scores, tear film breakup time, assessments of ocular symptoms, ocular surface disease index (OSDI) scores, dry eye treatment satisfaction, visual function-14 questionnaires, and adverse events. Results: The intent-to-treat data set included 105 patients randomized to Test Product (n = 52) or Control Product (n = 53). Patients primarily were between the ages of 18-64 years (70.5%), female (73.3%), white (93.3%), and not Hispanic (81.9%). Patients in the Test Product group exhibited significantly lower mean corneal staining scores than the Control Product group at day 14 (P = 0.0009) and day 42 (P = 0.0106), and significantly lower mean conjunctival staining scores at day 28 (P = 0.0475) and day 42 (P = 0.0009). Patients in both treatment groups reported significant reductions in the mean scores for the ocular symptoms of dryness, gritty/sandy feeling, and burning (P = 0.0021 for all comparisons to baseline). Lastly, a significantly lower OSDI score than baseline was reported at day 42 by patients in both the Test Product (P = 0.0013) and Control Product (P < 0.0001) groups. Conclusions: The results of this study indicate that the Test Product significantly reduced corneal and conjunctival staining, indicating a reduction in disease severity. Evaluations of ocular staining scores provide clinically meaningful evidence of dry eye severity and are an important indicator of dry eye disease progression.
1 Corona Research Consultants , El Paso, Texas.
This article was published in the following journal.
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20653478
- DOI: http://dx.doi.org/10.1089/jop.2010.0025
Medical and Biotech [MESH] Definitions
The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
The administration of therapeutic agents drop by drop, as eye drops, ear drops, or nose drops. It is also administered into a body space or cavity through a catheter. It differs from irrigation in that the irrigate is removed within minutes, but the instillate is left in place.
Polysaccharide gum from Sterculia urens (STERCULIA). It is used as a suspending or stabilizing agent in foods, cosmetics and pharmaceuticals; a bulk-forming laxative; a surgical lubricant and adhesive; and in the treatment of skin ulcers.
Directly Observed Therapy
A treatment method in which patients are under direct observation when they take their medication or receive their treatment. This method is designed to reduce the risk of treatment interruption and to ensure patient compliance.
Controlled Clinical Trial
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
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