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Joseph Glennon Vehige, Milton M Hom, Peter A Simmons, David A Hollander; Clinical comparison of gel-type artificial tears. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2879. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
For many dry eye patients, artificial tears with higher viscosity, or gel-type tears, are preferred for their extended efficacy. Tolerability of these products may be reduced compared with lower viscosity formulas due to blur, stickiness, and build-up of residue on the lids and lashes. This study compared the tolerability of a new high viscosity formula containing 1% carboxymethylcellulose, glycerin and osmoprotectants, with two existing gel products.
93 dry eye patients were enrolled at a single clinical site in this cross-over study, and were randomized to receive either the new formula (OGD, Refresh Optive Gel Drops, Allergan), or 1 of 2 existing gel-type tears: Systane Gel Drops (SGD, Alcon); or Genteal Lubricant Gel Drops (GGD, Novartis). Tolerability was assessed with an 8-item visual analog scale consisting of 4 positive and 4 negative attributes. Visual acuity, Tear Break-up Time (TBUT), and subjective experience was assessed 5 and 30 minutes following drop instillation. Following a 1-week wash-out, patients used their first test product, dosed as needed but at least 2X a day for 2 weeks. After a follow-up visit, patients washed out for 1 week and then used their 2nd product for 2 weeks. Tolerability and other variables were compared overall, and for each use individually.
79 patients completed the study, with 40, 19, and 20 in the OGD, SGD, and GGD groups respectively. All 3 products scored on average > 60 for positive and < 30 for negative tolerability attributes. Individual results indicated that OGD was superior to SGD for better comfort (p=0.047) and clear vision (p=0.040) when used second, and less stickiness (p=0.020) when used first. Other comparisons were not significantly different (p>0.05). Visual acuity at 5 and 30 minutes post-drop instillation was within 4 letters of 20/20 (range 46.05 to 51.94), across times and treatments. Post-drop TBUT was also similar for all treatments. The majority of subjects found all products acceptable.
The clinical profiles of the 3 products were similar, indicating that the new formula is as tolerable as either existing product. However, there were some indications that OGD, particularly when used following SGD, was perceived as superior. The post-drop visual acuity readings indicate that these products, although more viscous than many tear formulas, do not significantly impact vision.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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