NGF Treatment for Patients With Neuropathic Corneal Pain | Clinical Trial | StuddyBuddy@endsection NGF Treatment for Patients With Neuropathic Corneal Pain
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Withdrawn NCT05700864

NGF Treatment for Patients With Neuropathic Corneal Pain

Conditions: Corneal Disease, Neuropathy

Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Sponsor: Tufts Medical Center

Location: United States

Summary

This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).

Eligibility Criteria

Inclusion Criteria:Male or female aged ≥ 18 yearsSymptoms of neuropathic corneal pain at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.Positive ICVM findingsIf female with childbearing potential, have a negative pregnancy testBest corrected distance visual acuity, using corrective lenses if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200)Satisfying all Informed Consent requirementsAbility and willingness to comply with study proceduresAbility to speak and understand the English language sufficiently to understand the study, provide written consent, and allow completion of all study assessmentsExclusion Criteria:Evidence of any active ocular infectionEvidence of any intraocular inflammationEvidence of any persistent epithelial defect/ulcerEvidence of any corneal scar/corneal edemaPresence of any other ocular conditions that require topical medicationsHistory of severe systemic allergy or severe ocular allergyInability to suspend topical medications during the duration of the studyInability to suspend oral medications for NCP.No changes in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX)History of any ocular surgery within three months before study Visit 1(day 0)Ocular surgery expected during the 16 weeks of the trialUse of refractive/therapeutic contact lenses during the study periodFemale patients that are pregnant/have a positive pregnancy test result/are breast-feeding/intend to become pregnant during the study treatment periodDrug addiction/alcohol abuse within the last yearParticipation in another clinical trial

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05700864). StuddyBuddy aggregates publicly available trial information.