ArticleJournal of ophthalmology2023
Efficacy and Safety of an Ophthalmic DMPC-Based Nanoemulsion in Patients with Dry Eye Disease: A Phase I/II Randomized Clinical Trial.
Article in Journal of ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04111965 (Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients), which is not on this map. Cited by 3 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.
Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients
Who cites it
3 citing papers in PubMed, 7 citations in OpenAlex.
- The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2023Trial
- Nanomedicine in Ophthalmology: From Bench to Bedside.Journal of clinical medicine · 2024Review
- Advancing Gastrointestinal Health: Curcumin's Efficacy and Nanopreparations.Molecules (Basel, Switzerland) · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: The goals of this study were to evaluate the safety and efficacy of an ophthalmic 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC)-based nanoemulsion (Nanodrop®) in patients with dry eye disease (DED). Methods: This was a randomized phase I/II multicentric, prospective, double-blind clinical trial. Patients (phase I: Results: For the phase I portion of the study, there were no differences between groups regarding the incidence of AE. All related-AE symptoms in both groups were mild and expected. For the phase II subset, there was a significant reduction in OSDI scores at day 29 and noninferiority between treatments was confirmed ( Conclusions: Topical application of PRO-176 is as safe and effective as the controls. Both groups were clinically similar in terms of efficacy and safety. The results support the hypothesis that ophthalmic DMPC-based nanoemulsion may improve clinical parameters and symptoms in patients with DED. This trial is registered with NCT04111965.
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.