Evidence map›Paper›PMID 39060700›Full record

ArticleOphthalmology and therapy2024

Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration Desonide Phosphate in Dry Eye Disease Treatment.

Pasquale Aragona, Giuseppe Giannaccare, Edoardo Dammino, Fabiana D'Esposito, Paola Genovese, Elisa Imelde Postorino, Claudine Civiale, Maria Grazia Mazzone, Caterina Gagliano

Erratum issuedAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Pasquale AragonaUnità 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.ORCID http://orcid.org/0000-0002-9582-9799
Giuseppe GiannaccareOphthalmology Residency Program Eye Clinic, University of Cagliari, Via Università, 40, 09124, Cagliari, Italy.
Edoardo DamminoFaculty of Medicine, University of Catania, Piazza Università, 95123, Catania, Italy.
Fabiana D'EspositoImperial College Ophthalmic Research Group Unit, Imperial College, London, SW7 2AZ, UK.
Paola GenoveseUnità 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.
Elisa Imelde PostorinoUnità 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.
Claudine CivialeSIFI S.p.A., Via Ercole Patti 36, Aci San Antonio, 95025, Catania, Italy. claudine.civiale@sifigroup.com.
Maria Grazia MazzoneSIFI S.p.A., Via Ercole Patti 36, Aci San Antonio, 95025, Catania, Italy.
Caterina GaglianoDepartment of Medicine and Surgery, University of Enna "Kore", Piazza dell'Università, 94100, Enna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients 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%.

methodsThis 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.

resultsThirty 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.

conclusionsthe 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.

Indexed as

DesonideDry eye diseaseOcular surfaceXanthan gum

Identifiers

PMID39060700
PMCPMC11408441

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.