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NCT02116244 · ClinicalTrials.gov registry record · Phase 2
Civamide Nasal Solution for the Treatment of Dry Eye
A Phase 2 study, sponsored by Winston Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT02116244 is a Phase 2 study that has completed, run by Winston Laboratories. The registered enrollment target is 31 participants.
The verdict
NCT02116244, a Phase 2 study, has completed, sponsored by Winston Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. Millions of people suffer from one form of the disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a broad range of symptoms including discomfort, irritation, burning, itching, redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue. Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide release and subsequent desensitization to further stimulation of the trigeminovascular system. This provides a pharmacological rational for intranasal route of administration for disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received Civamide via intranasal administration experienced lacrimation (tearing). This led to the hypothesis that Civamide Nasal Solution might be an appropriate treatment for Dry Eye Syndrome.
Interventions
- DRUG Civamide Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02116244
The ClinicalTrials.gov registry entry for NCT02116244 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winston Laboratories, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Civamide Nasal Spray is the first listed.
NCT02116244 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02116244 about?
NCT02116244 is a clinical study titled "Civamide Nasal Solution for the Treatment of Dry Eye". Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. Millions of people suffer from one form of the disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a broad range of symptoms...
What is the current status of trial NCT02116244?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2014-05. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02116244?
The interventions under investigation include: Civamide Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT02116244?
This trial is sponsored by Winston Laboratories, which has 8 total clinical trials registered on ClinicalTrials.gov.
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