Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial

• Published in: Current eye research Vol. 46; no. 7; pp. 919 - 929
• Main Authors: Belalcázar-Rey, Sandra, Sánchez Huerta, Valeria, Ochoa-Tabares, Juan C, Altamirano Vallejo, Samuel, Soto-Gómez, Abraham, Suárez-Velasco, Rubén, García-Félix, Filiberto, Baiza-Durán, Leopoldo, Olvera-Montaño, Oscar, Muñoz-Villegas, Patricia
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03-07-2021
• Subjects: Administration, Ophthalmic; Adult; Aged; Aged, 80 and over; Chondroitin Sulfates - administration & dosage; Chondroitin Sulfates - adverse effects; Double-Blind Method; Drug Combinations; Dry eye disease; Dry Eye Syndromes - drug therapy; Dry Eye Syndromes - physiopathology; Female; Fluorophotometry; Humans; Hyaluronic Acid - administration & dosage; Hyaluronic Acid - adverse effects; Intraocular Pressure - physiology; Male; Middle Aged; ocular lubricants; ocular surface; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; sodium hyaluronate/chondroitin sulfate; Tears - physiology; Treatment Outcome; Visual Acuity - physiology; Young Adult; ocular lubricants; sodium hyaluronate/chondroitin sulfate; Dry eye disease; ocular surface
• ISSN: 0271-3683; 1460-2202
• DOI: 10.1080/02713683.2020.1849733

Purpose: To evaluate the efficacy of a preservative free sodium hyaluronate/chondroitin sulfate ophthalmic solution (SH/CS-PF) in patients with dry eye disease (DED).
Methods: This was a randomized phase IV, multicentric, prospective, double-blind clinical trial. Intent-to-treat (ITT) and per-protocol (PP) analyses were performed. Patients were assigned to receive either SH/CS-PF, Systane® Ultra (PEG/PG) or Systane® Ultra PF (PEG/PG-PF) for 90 days. A total of 326 patients were included in the ITT, and 217 in the PP analysis. Efficacy endpoints were goblet cell density, Nelson's grades (conjunctival impression cytology), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and Schirmer's test. Other parameters included were tolerability, measured by the ocular symptomatology; and safety, measured through corneal staining, intraocular pressure, visual acuity and adverse events.
Results: In the ITT, there was a significant increase in mean goblet cell density in all treatments compared with their baseline (28.4% vs 21.4% and 30.8%), without difference between arms (p = .159). Eyes exposed to SH/CS-PF, PEG/PG and PEG/PG-PF showed Grade 0-I squamous metaplasia (85.5%, 87.9% and 93.2%, respectively). Similar improvements were observed for TBUT (1.24 ± 2.3s vs 1.27 ± 2.4s and 1.39 ± 2.3s) and OSDI scores at day 90 (−8.81 ± 8.6 vs −7.95 ± 9.2 and −8.78 ± 9.8), although no significant intergroup difference was found. Schirmer's test also presented improvement compared to baseline (1.38 ± 4.9 vs 1.50 ± 4.7 and 2.63 ± 5.9), with a significantly higher variation for PEG/PG-PF. There were no significant differences between treatments for any tolerability and safety parameter, nor between ITT and PP analyses for any outcome.
Conclusions: The topical application of SH/CS-PF is as effective, safe and well tolerated as that of PEG/PG or PEG/PG-PF. The results suggest that SH/CS-PF may lead to normalization of clinical parameters and symptom alleviation in patients treated for DED.