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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 is a Phase 2 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 113 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04957758
The ClinicalTrials.gov registry entry for NCT04957758 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oyster Point Pharma, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.
NCT04957758 reports 0 study locations.
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.
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