Trial reportClinical ophthalmology (Auckland, N.Z.)2020
Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study.
Trial report in Clinical ophthalmology (Auckland, N.Z.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 25 citations in OpenAlex.
- Patient Experience with ABBV-444, a Proof-of-Concept Study for a Novel Artificial Tear with Trehalose and Sodium Hyaluronate for Dry Eye Symptoms.Clinical optometry · 2025Trial
- Effects of Carboxymethylcellulose Artificial Tears on Ocular Surface Microbiome Diversity and Composition, A Randomized Controlled Trial.Translational vision science & technology · 2023Trial
- ENRICHED trial of preservative-free lubricants in dry eye disease.Scientific reports · 2026Observational
- A Randomized Multicenter Study Comparing Low-Viscosity with Comparator 0.3% Hyaluronic Acid for the Treatment of Dry Eye Disease.Ophthalmology and therapy · 2026Article
- Advances in Pharmacotherapy and Physiotherapy for Dry Eye Disease: Molecular Mechanisms and Future Directions-A Narrative Literature Review.International journal of molecular sciences · 2026Review
- Comparative Performance of Artificial Tear Drops Assessed with Objective Non-Invasive Imaging.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Ocular complaints and diagnoses in spaceflight.NPJ microgravity · 2024Article
- Impact of dry eye disease treatment on patient quality of life.Frontiers in medicine · 2024Review
- Assessing the Effects of 0.3% Carboxymethylcellulose Tear Substitute Treatment on Symptoms and Signs of Dry Eye Disease in Elderly Population: A Prospective Longitudinal Study.Journal of clinical medicine · 2023Article
- Artificial tears: Promising treatment or silent threat to public health?Health science reports · 2023Article
- Ocular conditions and injuries, detection and management in spaceflight.NPJ microgravity · 2023Review
- Artificial Tears: A Systematic Review.Clinical optometry · 2023Review
- Personalized Management of Dry Eye Disease: Beyond Artificial Tears.Clinical ophthalmology (Auckland, N.Z.) · 2022Review
- Efficacy of Nonpreserved Sodium Hyaluronate Artificial Tears in Dry Eye Disease Patients Treated with Prostaglandin Analogs for Primary Open-Angle Glaucoma: A Prospective, Nonrandomized, Open-Label Pilot Study.Journal of ophthalmology · 2022Article
- Cellulosic Polymers for Enhancing Drug Bioavailability in Ocular Drug Delivery Systems.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Gel-Based Materials for Ophthalmic Drug Delivery.Gels (Basel, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye.
methodsA preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity.
resultsA total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was -16.9±17.5 for CMC-HA and -16.0±16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved (
conclusionThe new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients.
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