Trial reportCornea2016
Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study.
Trial report in Cornea, 2016. 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 49 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.
A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)
Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
Who cites it
49 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Aqueous-deficient dry eye disease: Preferred practice pattern guidelines on clinical approach, diagnosis, and management.Indian journal of ophthalmology · 2023Guideline
- Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis.International journal of clinical pharmacy · 2022Pooled it
- Corneal lymphangiogenesis as a potential target in dry eye disease - a systematic review.Survey of ophthalmologyPooled it
- Trial
- Efficacy and safety of abatacept in active primary Sjögren's syndrome: results of a phase III, randomised, placebo-controlled trial.Annals of the rheumatic diseases · 2021Trial
- Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease.European journal of ophthalmology · 2019Trial
- Corneal Fluorescein Staining in FDA-Reviewed Dry Eye Registrational Clinical Trials: Evidence of Limited Endpoint Responsiveness.Ophthalmic research · 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
- Real-World Experience with Lifitegrast Ophthalmic Solution in Patients with Dry Eye Disease: A Provider Survey in the USA and Canada.Ophthalmology and therapy · 2025Article
- Overview of Dry Eye Disease for Primary Care Physicians.Medicina (Kaunas, Lithuania) · 2025Review
- Article
- New advances in medical management of dry eye: optimizing treatment strategies for enhanced relief.International ophthalmology · 2024Review
- Managing Dry Eye Disease with Novel Medications: Mechanism, Study Validity, Safety, Efficacy, and Practical Application.Pharmacy (Basel, Switzerland) · 2024Review
- Tolerability of Current Treatments for Dry Eye Disease: A Review of Approved and Investigational Therapies.Clinical ophthalmology (Auckland, N.Z.) · 2024Review
- NLRP3 Inflammasome as a Potential Therapeutic Target in Dry Eye Disease.International journal of molecular sciences · 2023Review
- Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient Eyedrop for Dry Eye Disease: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2022Review
- Olive Pomace Phenolic Compounds: From an Agro-Industrial By-Product to a Promising Ocular Surface Protection for Dry Eye Disease.Journal of clinical medicine · 2022Article
- Selective Pharmacologic Therapies for Dry Eye Disease Treatment: Efficacy, Tolerability, and Safety Data Review from Preclinical Studies and Pivotal Trials.Ophthalmology and therapy · 2022Review
- Reduction of Artificial Tears and Use of Adjunctive Dry Eye Therapies After Lifitegrast Treatment: Evidence from Clinical and Real-World Studies.Clinical ophthalmology (Auckland, N.Z.) · 2022Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo.
methodsSONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma.
resultsThe safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression.
conclusionsLifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events.
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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.