Related Experiment Video
Updated: Jun 19, 2025
Comparing Objective Conjunctival Hyperemia Grading and the Ocular Surface Disease Index Score in Dry Eye Syndrome During COVID-19
Published on: May 25, 2022
Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration
Pasquale Aragona1, Giuseppe Giannaccare2, Edoardo Dammino3
1Unità Operativa Complessa (U.O.C.) di Oftalmologia, Ophthalmology Clinic, Department of Biomedical Sciences, Scuola di Specializzazione in Oftalmologia, University of Messina, Piazza Pugliatti, 1, 98122, Messina, Italy. pasquale.aragona@unime.it.
Introduction:
Patients with dry eye disease (DED) complain of a multitude of symptoms that affect their visual function and quality of life (QoL). This clinical investigation assessed the performance, tolerance, and safety of a novel preservative-free ophthalmic solution containing xanthan gum 0.2% and desonide sodium phosphate 0.025%.
Methods:
This was an observational, prospective, multicentric, and post-market clinical investigation to assess the effect of three times a day instillation of the study formulation in patients suffering from DED. The primary objective was to achieve a 50% reduction in conjunctival hyperemia index as assessed with the OCULUS Keratograph after 1 month of treatment compared to baseline values. The secondary objectives included patient-reported outcomes, clinical performance, and safety.
Results:
Thirty patients were enrolled (21 women, 9 men) with a mean age of 61.10 ± 14.53 years. The instillation of the study formulation was associated with a significant reduction in redness scores after 1 month of treatment compared to baseline (mean - 0.51 ± 0.51; p ≤ 0.0001). Although the primary endpoint was not completely met, a 50% reduction in the conjunctival hyperemia index was achieved in 23% of the participants, and 77% showed a reduction of 26% of the same index. In addition, the ophthalmic solution significantly increased tear film break-up time, and a significant reduction of corneal and conjunctival staining with fluorescein was achieved. It also reduced DED symptoms and had a very good safety profile.
Conclusions:
the study formulation produced a significant improvement in the signs, symptoms, and QoL of patients with mild to moderate DED with a good safety profile after 1 month of treatment.
