Ophthalmology and therapy · 2026
A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain.
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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, Ifantides Cristos
Аннотация
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.
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.