Comparison of 0.2% and 0.18% hyaluronate eye drops in patients with moderate to severe dry eye with keratitis or keratoconjunctivitis
Authors Groß D, Childs M, Piaton J
Received 31 December 2016
Accepted for publication 23 February 2017
Published 6 April 2017 Volume 2017:11 Pages 631—638
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Dorothea Groß,1 Marc Childs,2 Jean-Marie Piaton3
1Ursapharm Arzneimittel GmbH, Saarbrücken, Germany; 2Laboratoires Delbert, Paris, 3Ophthalmic Practice, Domont, France
Purpose: Comparison of efficacy and safety of 0.2% and 0.18% hyaluronic acid (HA) eye drops three times a day (tid) in patients with moderate to severe dry eye disease, related to keratitis or keratoconjunctivitis.
Patients and methods: Prospective, multicenter, randomized, single-masked, phase IIIb, noninferiority study (0.2% HA vs 0.18% HA) in two parallel groups over a period of 84 days. N=70 patients were evaluated. Primary efficacy outcome was ocular surface (OS) staining change on day 35 (D35), compared to baseline. Fluorescein and lissamine green were used for staining of cornea and conjunctiva. Secondary efficacy outcome included tear film breakup time, OS staining score on day 84 (D84), ocular comfort index, as well as patients’ and doctors’ evaluation.
Results: Compared to day 0 (D0), 0.2% HA achieved a 47.7% reduction in staining score (-3.00±2.81 [standard deviation] points, n=38 patients) at D35; 0.18% HA showed a 41.2% reduction (-2.59±2.20 [standard deviation] points, n=32 patients). Statistical analysis showed noninferiority in efficacy of 0.2% HA compared to 0.18% HA on D35. At D84, the reduction in staining score had further increased to 64.5% for 0.2% HA and to 56.4% for 0.18% HA. Both eye drops improved tear film breakup time and ocular comfort index values. Investigators and patients assessed both treatments with 5 of 7 points (Likert Scale, medians). The rate of adverse events (AE) was 2.3% for 0.2% HA and 7.1% for 0.18% HA with no serious AE.
Conclusion: 0.2% and 0.18% HA eye drops significantly improved signs and symptoms of dry eye disease and were well tolerated with few AEs. Noninferiority of 0.2% HA compared to 0.18% HA was demonstrated for reduction of OS lesions. In some parameters, there was a nonsignificant trend in favor of 0.2% HA concentration.
Keywords: dry eye, hyaluronic acid, ocular surface lesions, ocular staining, keratoconjunctivitis sicca, eye drops, unpreserved, hyaluronate, fluorescein, lissamine green
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