Trial reportEuropean journal of ophthalmology2019
Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease.
Trial report in European journal of ophthalmology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed, 37 citations in OpenAlex.
- Management of Dry Eye Disease Pre- and Post-Cataract Surgery: A Personalized Approach.Journal of personalized medicine · 2026Review
- Computational pharmacovigilance of Lifitegrast in dry eye disease using machine learning and network toxicology.NPJ digital medicine · 2026Article
- Efficacy and Safety of Reproxalap 0.25% Ophthalmic Solution in Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- Lifitegrast Degradation: Products and Pathways.Pharmaceutics · 2025Article
- Utilizing AI for the Identification and Validation of Novel Therapeutic Targets and Repurposed Drugs for Endometriosis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Lifitegrast in Treatment of Dry Eye Disease-A Practical, Narrative Expert Review.Journal of ophthalmology · 2025Review
- Preliminary study of cyclosporine A/Lifitegrast subconjunctival sustained-release drug membrane in the treatment of dry eyes.Eye and vision (London, England) · 2024Article
- Tolerability of Current Treatments for Dry Eye Disease: A Review of Approved and Investigational Therapies.Clinical ophthalmology (Auckland, N.Z.) · 2024Review
- Selective Pharmacologic Therapies for Dry Eye Disease Treatment: Efficacy, Tolerability, and Safety Data Review from Preclinical Studies and Pivotal Trials.Ophthalmology and therapy · 2022Review
- Review
- A Systematic Review on the Association Between Tear Film Metrics and Higher Order Aberrations in Dry Eye Disease and Treatment.Ophthalmology and therapy · 2022Review
- Sjögren syndrome: looking forward to the future.Therapeutic advances in musculoskeletal disease · 2022Review
- Review
- The Immunological Basis of Dry Eye Disease and Current Topical Treatment Options.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2020Review
- Treatment Satisfaction Among Patients Using Anti-Inflammatory Topical Medications for Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2020Article
- Physician Satisfaction with Anti-Inflammatory Topical Medications for the Treatment of Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2020Article
- The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery.Clinical ophthalmology (Auckland, N.Z.) · 2020Article
- Safety and efficacy of lifitegrast 5% ophthalmic solution in contact lens discomfort.Clinical ophthalmology (Auckland, N.Z.) · 2018Article
- Lifitegrast: a novel drug for patients with dry eye disease.Therapeutic advances in ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCharacterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease.
methodsPooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score ⩾1 and ⩽10 mm, eye dryness score ⩾40 (visual analog scale 0-100), corneal staining score ⩾2.0 (0-4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment-emergent adverse events and drop comfort scores were assessed.
resultsOverall, 2464 participants (lifitegrast, n = 1287; placebo, n = 1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (> 5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8).
conclusionLifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.
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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.