ReviewThe ocular surface2017
TFOS DEWS II Clinical Trial Design Report.
Review in The ocular surface, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 52 papers, 3 of them syntheses that pooled 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.
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.
Multi-centre, Randomised,Parallel-group, Controlled (Placebo), Double-blind Study to Evaluate the Efficacy, Ocular Tolerability and Safety of Vizol S Lipid Balance in the Adult Patient Population With Moderate to Severe Dry Eye for up to 30 Days
Multicentre, Randomized, Controlled, Double-blind, Parallel Design Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vizol S DIGI EYE in the Adult Patient Population With Moderate to Severe Dry Eye Disease for up to 28 Days
Who cites it
52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Outcome parameters in studies investigating dry eye disease: A systematic literature review.Acta ophthalmologica · 2026Pooled it
- Bridging the gap in managing dry eye disease: a consensus report by the Taiwan society of cataract and refractive surgeons.BMC ophthalmology · 2024Guideline
- Omega-3 and omega-6 polyunsaturated fatty acids for dry eye disease.The Cochrane database of systematic reviews · 2019Pooled it
- Safety and Effectiveness of Iota-Carrageenan Eye Drops for the Treatment of Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2026Trial
- Intereye Agreement in Dry-Eye Signs in the DREAM Study: Implications for Future Dry-Eye Trials.Cornea · 2025Trial
- A clinical study of topical treatment for thyroid-associated ophthalmopathy with dry eye syndrome.BMC ophthalmology · 2023Trial
- Trial
- Selecting Vehicle Comparators in Dry Eye Disease Clinical Trials: Implications for Efficacy and Safety Assessment and Regulatory Outcomes.Ophthalmology and therapy · 2026Article
- Regional Tear Film Quality Changes Across Eye Gaze Directions Revealed by Spatial Mapping and Threshold Sensitivity Analysis.Journal of clinical medicine · 2026Article
- Evaluation of corneal morphology, pupillometry, and ocular surface parameters in Fabry disease patients: correlation with plasma Lyso-Gb3 levels.International ophthalmology · 2026Article
- Experts Perspectives on Current Practices and Challenges of Diagnosis and Treatment of Dry Eye Disease across Europe and Central Asia.Ophthalmology and therapy · 2026Article
- Evaluation of Dry Eye Parameters in Patients with Papillary Thyroid Carcinoma.Journal of clinical medicine · 2026Article
- Efficacy and Safety of SA001 in Patients with Primary Sjögren's Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Qualitative analysis and clinical implications of lipid layer thickness variability: A retrospective, cross-sectional study.PloS one · 2026Article
- Diagnostic methods for managing dry eyes.World journal of methodology · 2025Article
- Big Data on Climatic and Environmental Parameters Associated with Acute Ocular Surface Symptoms and Therapeutic Assessment: Eye Drops Sales, Google Trends and Environmental Changes.Vision (Basel, Switzerland) · 2025Article
- The Relationship Between Composite Inflammatory Indices and Dry Eye in Hashimoto's Disease-Induced Hypothyroid Patients.Biomedicines · 2025Article
- Article
- Insulin Nanoemulsion Eye Drops for the Treatment of Dry Eye Disease in Sjögren's Disease: A Randomized Clinical Trial Phase I/II.Vision (Basel, Switzerland) · 2025Article
- Advanced and interpretable corneal staining assessment through fine grained knowledge distillation.NPJ digital medicine · 2025Article
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 10 institutions in 4 countries.
Funding
Abstract
The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED. Therefore the report advocates for conducting good quality studies, as described, going forward. A key recommendation for future studies is conduct consistent with Good Clinical Practice (GCP), including use of Good Manufacturing Practice (GMP) quality clinical trial material. The report also recommends that the design, treatments, and sample size be consistent with the investigational treatment, the objectives of the study, and the phase of development. Other recommendations for pivotal studies are a priori selection of the outcome measure, and an appropriate sample size.
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.