Trial reportBMC ophthalmology2016
Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.
Trial report in BMC ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01657253 (A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye), which is not on this map. Cited by 8 papers.
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.
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.
A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
Who cites it
8 citing papers in PubMed, 25 citations in OpenAlex.
- Enhancing Corneal Sensitivity in Diabetic Patients Through an Innovative Ophthalmic Solution: In Vivo and Vitro Results.Journal of clinical medicine · 2025Article
- Observational Clinical Investigation Evaluating an Ophthalmic Solution Containing Xanthan Gum and Low Concentration Desonide Phosphate in Dry Eye Disease Treatment.Ophthalmology and therapy · 2024Article
- Impact of dry eye disease treatment on patient quality of life.Frontiers in medicine · 2024Review
- Influence of Environmental Factors with Clinical Signs and Symptoms in the Management of Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2024Article
- A Review of Chondroitin Sulfate's Preparation, Properties, Functions, and Applications.Molecules (Basel, Switzerland) · 2023Review
- Artificial Tears: A Systematic Review.Clinical optometry · 2023Review
- Heterologous production of chondroitin.Biotechnology reports (Amsterdam, Netherlands) · 2022Review
- Preparation and Evaluation of a Xanthan Gum-Containing Linezolid Ophthalmic Solution for Topical Treatment of Experimental Bacterial Keratitis.Pharmaceutical research · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention.
methodsA phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains.
resultsThe primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions.
conclusionsXanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease.
trial registrationClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.