Phase 2
N=113
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
Neurotrophic Keratopathy
Bottom Line
View on ClinicalTrials.gov: NCT04957758 ↗Enrolled (actual)
113
Serious AEs
7.1%
Results posted
May 2024
Primary outcome: Primary: Mean Change From Baseline in Corneal Fluorescein Staining — -0.6; -0.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OC-01 (varenicline) nasal spray 1.2 mg/ml (Drug); Placebo (vehicle) nasal spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oyster Point Pharma, Inc.
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Corneal Fluorescein Staining |
-0.6; -0.9 | — |
| SECONDARY Mean Change From Baseline in Visual Acuity at Week 8 |
0.6; 1.5 | — |
Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age at Visit 1.
- Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
- Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
- Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
- If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.
Exclusion Criteria
- Have Stage 2 or Stage 3 NK affecting one or both eyes.
- Have ocular graft versus host disease or Stevens-Johnson syndrome.
- Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
- Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
- Have severe blepharitis and/or severe meibomian gland disease in the study eye.
Data sourced from ClinicalTrials.gov (NCT04957758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.