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

Authors

• Anat Galor
• Christopher Rapuano
• Alice Epitropoulos
• Jayne Weiss
• Stephen Pflugfelder
• Preeya Gupta
• Deepinder Dhaliwal
• Laura Periman
• Bonnie An Henderson
• Thanh T Nguyen
• Chameen Samarawickrama
• Helen Wu
• Tomasz Stryjewski
• James A Stefater
• Mark Hinds
• Pooja Bhindi
• Cristos Ifantides

Language

English

Publication Date

6-1-2026

Journal

Ophthalmology and Therapy

DOI

10.1007/s40123-026-01392-3

PMID

42101550

PMCID

PMC13249988

PubMedCentral® Posted Date

5-8-2026

PubMedCentral® Full Text Version

Post-print

Abstract

Introduction: No 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).

Methods: This 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.

Results: Unilateral 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.

Conclusion: A 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 registration: ClinicalTrials.gov identifier: NCT06479382.

Keywords

Chronic ocular surface pain, Ocular surface disease, Eye pain, Cryotherapy, Dry eye disease

Published Open-Access

yes

Recommended Citation

Galor, Anat; Rapuano, Christopher; Epitropoulos, Alice; et al., "A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain" (2026). Faculty, Staff and Students Publications. 7392.
https://digitalcommons.library.tmc.edu/baylor_docs/7392