At a glance
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A Long-term Extension Study to Evaluate the Safety and Efficacy of OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj Ophthalmic Solution in Patients With Stage 1 Neurotrophic Keratitis Who Enrolled in the DEFENDO Study (NGF0120)
In Brief
An observational study evaluating Cenegemin in the DEFENDO Study for Neurotrophic Keratitis. Completed, enrolled 24 participants across 4 sites.
Detailed Summary
Primary Objective To evaluate the long-term safety and efficacy (healing) of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 neurotrophic keratitis (NK) patients who enrolled in the DEFENDO study. Secondary Objective To evaluate the long-term efficacy of OXERVATE® 0.002% (20 mcg/mL) cenergemin-bkbj ophthalmic solution in terms of corneal sensitivity, Schirmer I test, tear film break-up time (TFBUT), best corrected distance visual acuity (BCDVA), and quality of life at 24 and 30 months post-treatment
Study Details
Timeline
Interventions
Cenegemin as administered in the original DEFENDO Study. Long-term safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered in Stage 1 Neurotrophic Keratitis (NK) patients enrolled in the original DEFENDO Study (NGF0120 / NCT04485546). No intervention was performed in this follow-up / extension study.