Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops (MT8) for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients
- Sponsor: Recordati Rare Diseases
- Principal Investigator: Evan Warner
- Study Coordinator: Kelly Boyd
Study Objective:
To determine the efficacy and safety of MT8 given as 1 drop 4x/day at 5, 25 and 50 µg/mL for 8 weeks and select the dose with the best benefit risk ratio.
Study Design:
Participants will be randomized 1:1:1:1 to receive 5 µg/mL MT8 given 1 drop QID, 25 µg/mL MT8 given 1 drop QID, 50 µg/mL MT8 given 1 drop QID or vehicle given 1 drop QID. Participants will complete 11 study visits over approximately 3 months.
Inclusion Criteria:
- Be a male or female aged ≥18 years
- Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow eye can be enrolled.
- Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the screening visit despite use of conventional non-surgical treatment
- Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
- Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
- Have a known hypersensitivity to one of the components of the study drug or procedural medications (eg, fluorescein), including to a compound chemically related to MT8
For the study eye:
- Have any active ocular infection (bacterial, viral, fungal or protozoal) or active inflammation not related to NK in the study eye.
- Have any other ocular disease requiring topical ocular treatment in the study eye during the course of the study treatment period, except for glaucoma if treated by preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks before screening and during the study),
- Have severe blepharitis and/or severe meibomian gland disease in the study eye.
- Have severe vision loss in the study eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment.
- Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
- Have a history of any ocular surgery (including laser or refractive surgical procedures) within 3 months before the Screening Visit in the study eye. An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the Stage 2 or 3 NK.
- Have a history of corneal transplantation in the study eye, except if performed to treat NK and at least 6 months prior screening.
- Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy, conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after the procedure) in the study eye.
- Use therapeutic contact lenses or wear contact lenses for refractive correction during the study treatment periods in the eye(s) with NK.
For the fellow eye:
- Have Stage 2 or 3 NK or perforation.
For any eye:
- Have a history of ocular cancer.
- Have had prior treatment with Oxervate™
Contact Kelly Boyd with questions, (608) 265-4589
For more information about this study, visit clinicaltrials.gov: REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients – Full Text View – ClinicalTrials.gov