The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corn… (NCT06637527) | Clinical Trial Compass
TerminatedPhase 2
The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain
Stopped: Study ended early to expedite development and enable earlier FDA discussions. Prior Phase 2 data (240 patients) showed favorable safety and placebo-like tolerability. Closure was not due to safety concerns.
United States18 participantsStarted 2024-10-15
Plain-language summary
The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged ≥ 18 years.
✓. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
✓. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
✓. Females of childbearing potential must have a negative pregnancy test.
✓. Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).
✓. Satisfying all Informed Consent requirements.
✓. Ability and willingness to comply with study procedures.
Exclusion criteria
✕. Evidence of any active ocular infection.
✕. Evidence of any intraocular inflammation.
✕
What they're measuring
1
Assess ocular pain using 0-10 visual analog scale (VAS)