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Introduction <p>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).</p> Methods <p>This was a prospective, randomized, double-masked, multicenter clinical feasibility study in adults aged 22–90&#xa0;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&#xa0;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&#xa0;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&#xa0;hoc analyses were conducted in eyes with peripheral-dominant pain based on proparacaine challenge. Adverse events (AEs) were recorded.</p> Results <p>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&#xa0;8 in the active versus sham arm. In eyes with peripheral-dominant pain, COP-Q eye pain severity improved significantly versus sham at week&#xa0;8 (nominal <i>p</i> = 0.042), and OPAS overall eye pain trended towards statistical significance (nominal <i>p</i> = 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 <i>p</i> = 0.041). No serious AEs occurred; the most common AE was transient conjunctival hyperemia.</p> Conclusion <p>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&#xa0;weeks.</p> Trial Registration <p>ClinicalTrials.gov identifier: NCT06479382.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月8日

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  • 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

摘要

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.