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

Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17.

Abstract

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.

Keywords: Artificial tear; Carboxymethylcellulose; Dry eye; Glycerin; Lubricant eye drop; Viscosity.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Ophthalmic
  • Adult
  • Aged
  • Carboxymethylcellulose Sodium / chemistry
  • Carboxymethylcellulose Sodium / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Dry Eye Syndromes / drug therapy*
  • Dry Eye Syndromes / physiopathology
  • Female
  • Glycerol / chemistry
  • Glycerol / therapeutic use*
  • Humans
  • Lubricant Eye Drops / chemistry
  • Lubricant Eye Drops / therapeutic use*
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Tears / physiology
  • Treatment Outcome
  • Viscosity

Substances

  • Drug Combinations
  • Lubricant Eye Drops
  • Ophthalmic Solutions
  • Carboxymethylcellulose Sodium
  • Glycerol