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

Authors

• Anat Galor, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
• Christopher Rapuano, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA.
• Alice Epitropoulos, Ophthalmic Surgeons & Consultants of Ohio, Columbus, OH, USA.
• Jayne Weiss, LSU Health Sciences Center - New OrleansFollow
• Stephen Pflugfelder, Department of Ophthalmology, Baylor College of Medicine, Houston, TX, USA.
• Preeya Gupta, Triangle Eye Consultants, Raleigh, NC, USA.
• Deepinder Dhaliwal, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
• Laura Periman, Periman Eye Institute, Seattle, WA, USA.
• Bonnie An Henderson, HelpMeSee, Jersey City, NJ, USA.
• Thanh T. Nguyen, Centre for Eye Research Australia, East Melbourne, Victoria, Australia.
• Chameen Samarawickrama, University of Sydney, Save Sight Institute, Sydney, Australia.
• Helen Wu, Newton Wellesley Eye Associates, Wellesley, MA, USA.
• Tomasz Stryjewski, Tallman Eye Associates, Andover, MA, USA.
• James A. Stefater, Ophthalmic Consultants of Boston, Boston, MA, USA.
• Mark Hinds, Ophthalmic Trial Australia, Brisbane, Australia.
• Pooja Bhindi, Innovative Eye Care, Adelaide, Australia.
• Cristos Ifantides, Tyson Eye and University of Colorado School of Medicine, Cape Coral, FL, USA. cristosMD@gmail.com.

Document Type

Article

Publication Date

6-1-2026

Publication Title

Ophthalmology and therapy

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.

First Page

2033

Last Page

2050

PubMed ID

42101550

Volume

15

Issue

6

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Recommended Citation

Galor, Anat; Rapuano, Christopher; Epitropoulos, Alice; Weiss, Jayne; Pflugfelder, Stephen; Gupta, Preeya; Dhaliwal, Deepinder; Periman, Laura; Henderson, Bonnie An; Nguyen, Thanh T.; Samarawickrama, Chameen; Wu, Helen; Stryjewski, Tomasz; Stefater, James A.; Hinds, Mark; Bhindi, Pooja; and Ifantides, Cristos, "A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain" (2026). School of Medicine Faculty Publications. 4854.
https://digitalscholar.lsuhsc.edu/som_facpubs/4854
10.1007/s40123-026-01392-3