Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study

Abstract

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. diminishing quality of life [3,4]. Artificial tears (lubricant eye drops or gels) are often used as primary therapy for mild to moderate disease and in combination with pharmacological agents or surgical procedures in more severe disease [5,6]. With better understanding of the roles of tears, tear film osmolarity, and ocular surface inflammation in dry eye disease [7-9], development of novel artificial lubricants has focused on

Dry Eye Disease: A Review of Epidemiology in Taiwan, and its Clinical Treatment and Merits

“…From baseline within 30 days with use of 0.5% carboxymethylcellulose sodium (CMC)/0.9% Glycerin (GLY) eye drops or 0.5% CMC artificial tears, dry eye signs and symptoms based on Schirmer Test, tear break up time (TBUT), corneal and conjunctival staining and OSDI are confirmed to have a significant improvement [121]. Similar findings were also found in another study which evaluated 1.0% CMC/0.9% GLY and 1.0% CMC eye drops for patients with moderate to severe dry eye [122]. Administration of seawater is thought to be more effective than treatment with carmellose artificial tears in reducing pro-inflammatory molecules, such as IL-1 beta and IL-6, in tears among patients with DED [123].…”

<p>Effect of Refresh Plus^® preservative-free lubricant eyedrops on tear ferning patterns in dry eye and normal eye subjects</p>

“…The drops contain sodium carboxymethylcellulose (CMC) 0.5% as the active ingredient, as well as sodium lactate and various electrolytes, including sodium chloride, potassium chloride, magnesium chloride, and calcium chloride. They can be used to relieve symptoms of dry eye, ie, irritation, burning, and discomfort 22…”

“…For example, tear-evaporation rate,15 Schirmer's test,16 phenol red thread,16 tear meniscus height (TMH),17 noninvasive tear breakup time (NITBUT),18 osmolarity,19 and the tear ferning (TF)20,21 test can be used to detect dry eye. Artificial tears can be used to lubricate the tear film and relieve some of the uncomfortable symptoms associated with moderate dry eye 22,23…”

Control System Applied to the Microinjection of Artificial Tears for Severe Dry Eye Treatment

“…Artificial tears viscosity, unlike density, is highly dependent on chemical composition and varies considerably between different commercial formulas. Bhojwani et al [32] reported measured values from 1 up to ∼600 Pa•s of dynamic viscosity for common high viscosity and low viscosity artificial tears at temperatures from 25 to 37 • C. Lievens et al [35] and Bhojwani et al [32] presented studies to determine the effect of tears viscosity on well-being in dry eye patients, and reported a slight improvement with the increase of viscosity, while some others reported no improvements at all.…”