Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04957758 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
A Phase 2 study, sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT04957758: Completed Phase 2 study, sponsored by Oyster Point Pharma.
NCT04957758 is a Phase 2 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04957758, a Phase 2 study, has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
Interventions
- DRUG Placebo (vehicle) nasal spray
- DRUG OC-01 (varenicline) nasal spray 1.2 mg/ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2023-04-28 |
| Phase | Phase 2 |
What the finished NCT04957758 record still lists
NCT04957758 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.
NCT04957758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04957758 about?
NCT04957758 is a clinical study titled "Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy". 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 kera...
What is the current status of trial NCT04957758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2021-06-17. Estimated completion is 2023-04-28.
What interventions are being tested in trial NCT04957758?
The interventions under investigation include: Placebo (vehicle) nasal spray (DRUG), OC-01 (varenicline) nasal spray 1.2 mg/ml (DRUG).
Who is sponsoring clinical trial NCT04957758?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04957758's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00748254 · 113 participants
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis
- NCT04753190 · 113 participants · NA
Light Timing Study
- NCT05799248 · 113 participants · Phase 3
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- NCT07216105 · 113 participants · Phase 1
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI