This prospective feasibility study evaluated the ophthalmic cooling device ETX-4143 — two metallic probes cooled to −20 °C applied to the bulbar conjunctiva for 4 minutes — in 5 adults with chronic ocular surface pain (COSP), tracking ocular pain, corneal nerve morphology, and immune cell dynamics via in vivo confocal microscopy over 12 weeks.
Ocular pain (COP-Q Eye Pain Severity Module) fell significantly from baseline at 2 weeks (−4.4 units, P=0.02), 6 weeks (−5.0, P=0.002), and 12 weeks (−5.8, P=0.001), with benefit progressing over time; corneal nerve morphology and clinical surface signs remained stable. Functional IVCM showed a transient rise in putative intraepithelial T-cell motility through 6 weeks, followed by a reduction at 12 weeks alongside decreased dendritic cell probing (P=0.049).
- Extremely small sample (n=5) limits generalizability and statistical power. - No randomized control arm; fellow eye served as untreated comparator, which cannot rule out systemic or placebo effects. - All participants received post-treatment corticosteroid drops per protocol, potentially confounding immune and clinical outcomes.
ETX-4143 appears safe and may reduce chronic ocular surface pain for up to 12 weeks, but with only 5 participants this is strictly hypothesis-generating — randomized controlled trials are needed before clinical adoption.
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