Evidence map›Paper›PMID 42704415›Full record

ArticleOphthalmology and therapy2026

Selecting Vehicle Comparators in Dry Eye Disease Clinical Trials: Implications for Efficacy and Safety Assessment and Regulatory Outcomes.

Isabella Tunon-Robinson, Suzanne Zheng, Cathy Zhao, Ashley K Nguyen, Laura Gomez-Freeman

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04030962 (A Multicenter, Vehicle-controlled, Double-Masked, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of AGN-242428 and AGN-231868 in Participants With Dry Eye Disease), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT04030962 phase1 / phase2completednot on this map

A Multicenter, Vehicle-controlled, Double-Masked, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of AGN-242428 and AGN-231868 in Participants With Dry Eye Disease

TypeinterventionalSponsorAbbVieRan2020 to 2022Enrolled292ConditionsDry Eye Disease, Dry Eye SyndromeArmsAGN-242428, AGN-231868, AGN-242428 Vehicle, AGN-231868 Vehicle, Lifitegrast 5% Ophthalmic Solution
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Isabella Tunon-RobinsonComputer Science Department, School of Computing and Augmented Intelligence, Arizona State University, Tempe, AZ, USA. itunonro@asu.edu.
Suzanne ZhengStatistics Department, AbbVie Inc., North Chicago, IL, USA.
Cathy ZhaoStatistics Department, AbbVie Inc., North Chicago, IL, USA.
Ashley K NguyenClinical Development, AbbVie Inc., Irvine, CA, USA.
Laura Gomez-FreemanDepartment of Ophthalmology, University of California San Diego, San Diego, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClinical trials evaluating investigational drugs for dry eye disease (DED) frequently employ vehicle comparators that include excipients (polymers, cyclodextrins, and oil-in-water emulsions) known to have palliative effects. When a saline-based vehicle without any palliative excipient is used as the comparator, the investigational drug only needs to show superiority over a minimally active control to achieve the trial's primary endpoint. Lifitegrast 5% received US Food and Drug Administration approval based on comparisons with its saline-based vehicle. This study evaluated the efficacy and safety outcomes of lifitegrast 5% compared with an investigational drug vehicle containing a palliative excipient.

methodsStage 2 of a 42-day randomized, double-masked, multicenter phase 1/2a study tested investigational drugs, their cyclodextrin-containing vehicles, and lifitegrast 5% administered bilaterally twice daily in patients with DED. The present post hoc analysis compared the lifitegrast group with one of the cyclodextrin-containing vehicle groups. Mixed-model repeated-measures analysis was used to evaluate changes from baseline in efficacy variables at day 42.

resultsThere were no significant differences in symptom and sign improvement between the lifitegrast group (N = 50) and the cyclodextrin-containing vehicle group (N = 49). Changes from baseline in visual analog scale symptom scores, Ocular Surface Disease Index scores, Schirmer scores, corneal and conjunctival staining scores, and tear break-up time were comparable between groups (all P values > 0.05). Treatment-related adverse events were more frequent in the lifitegrast group.

conclusionsThis study found no evidence of superiority of lifitegrast 5% to a vehicle containing cyclodextrin. Use of a saline-based vehicle as the control in registration studies sets a low bar for approval and makes it challenging to judge whether a drug provides benefits beyond current artificial tears. To provide evidence of added therapeutic benefit, comparators that are not treatments for DED should include palliative excipient(s) similar to those found in artificial tears.

trial registrationClinicalTrials.gov identifier NCT04030962.

Indexed as

Clinical trialDry eye diseaseLifitegrast efficacyPalliative excipientsVehicle comparators

Identifiers

PMID42704415

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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.