Evidence map›Paper›PMID 42101550›Full record

ArticleOphthalmology and therapy2026

A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain.

Anat Galor, Christopher Rapuano, Alice Epitropoulos, Jayne Weiss, Stephen Pflugfelder, Preeya Gupta, Deepinder Dhaliwal, Laura Periman, Bonnie An Henderson, Thanh T Nguyen and 7 more

Registry-linked trialAbstract read
PubMed Full text at PMC 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 NCT06479382 (A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06479382 nacompletednot on this map

A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain

TypeinterventionalSponsorEyeCool Therapeutics, Inc.Ran2024 to 2024Enrolled31ConditionsEye PainArmsETX-4143 2.0
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. A Scoping Review of Pharmacologic and Nonpharmacologic Interventions to Treat Chronic Ocular Pain.Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society · 2026
    Article
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

17 authors.

Anat GalorBascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
Christopher RapuanoWills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA.
Alice EpitropoulosOphthalmic Surgeons & Consultants of Ohio, Columbus, OH, USA.
Jayne WeissDepartment of Ophthalmology, Louisiana State University, New Orleans, LA, USA.
Stephen PflugfelderDepartment of Ophthalmology, Baylor College of Medicine, Houston, TX, USA.
Preeya GuptaTriangle Eye Consultants, Raleigh, NC, USA.
Deepinder DhaliwalDepartment of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
Laura PerimanPeriman Eye Institute, Seattle, WA, USA.
Bonnie An HendersonHelpMeSee, Jersey City, NJ, USA.
Thanh T NguyenCentre for Eye Research Australia, East Melbourne, Victoria, Australia.
Chameen SamarawickramaUniversity of Sydney, Save Sight Institute, Sydney, Australia.
Helen WuNewton Wellesley Eye Associates, Wellesley, MA, USA.
Tomasz StryjewskiTallman Eye Associates, Andover, MA, USA.
James A StefaterOphthalmic Consultants of Boston, Boston, MA, USA.
Mark HindsOphthalmic Trial Australia, Brisbane, Australia.
Pooja BhindiInnovative Eye Care, Adelaide, Australia.
Cristos IfantidesTyson Eye and University of Colorado School of Medicine, Cape Coral, FL, USA. cristosMD@gmail.com.ORCID http://orcid.org/0000-0003-2289-6656

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNo therapy is currently FDA approved to treat ocular pain. This study evaluated the safety and efficacy of a novel topical ocular cooling device for chronic ocular surface pain (COSP).

methodsThis was a prospective, randomized, double-masked, multicenter clinical feasibility study in adults aged 22-90 years with COSP. The intervention was a handheld device that applied cold temperatures to the conjunctival surface above the long ciliary nerves via two metallic contact surfaces at the 3 and 9 o'clock positions. Subjects were randomized 2:1 to a one-time, 4-min treatment with the active (frozen) or sham (refrigerated) device and followed for 8 weeks. Subjective pain was assessed via the visual analog scale (VAS), ocular pain assessment survey (OPAS), and chronic ocular pain questionnaire (COP-Q). Corneal sensitivity was evaluated with Cochet-Bonnet esthesiometry. Main outcomes were change from baseline in VAS, OPAS, and COP-Q scores. Post hoc analyses were conducted in eyes with peripheral-dominant pain based on proparacaine challenge. Adverse events (AEs) were recorded.

resultsUnilateral treatments were administered to 31 subjects (20 active, 11 sham). All three patient-reported outcomes (PROs) showed greater reductions in eye pain at week 8 in the active versus sham arm. In eyes with peripheral-dominant pain, COP-Q eye pain severity improved significantly versus sham at week 8 (nominal p = 0.042), and OPAS overall eye pain trended towards statistical significance (nominal p = 0.088). All three PROs exceeded thresholds for clinically meaningful improvement. Baseline corneal sensitivity was below normal in both groups and improved significantly only in the active group (nominal p = 0.041). No serious AEs occurred; the most common AE was transient conjunctival hyperemia.

conclusionA novel ocular surface cooling device is well tolerated and appears to provide durable relief of COSP in peripheral-dominant pain types for at least 8 weeks.

trial registrationClinicalTrials.gov identifier: NCT06479382.

Indexed as

Chronic ocular surface painCryotherapyDry eye diseaseEye painOcular surface disease

Identifiers

PMID42101550
PMCPMC13249988

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.