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NCT04140227 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
A Phase 3 study of Dry Eye Disease (DED), sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT04140227 is a Phase 3 study of Dry Eye Disease (DED) that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 256 participants, below the 406-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04140227, a Phase 3 study of Dry Eye Disease (DED), has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
Conditions Studied
Interventions
- DRUG NOV03
Study Locations (20)
California
- Bausch Site 110 - Glendale
- Bausch Site 121 - Long Beach
- Bausch Site 102 - Mission Hills
- Bausch Site 101 - Newport Beach
- Bausch Site 116 - Rancho Cordova
- Bausch Site 103 - Torrance
- Bausch Site 123 - Torrance
Florida
- Bausch Site 129 - Fort Myers
- Bausch Site 115 - Jacksonville
- Bausch Site 106 - Largo
- Bausch Site 117 - Tampa
Missouri
- Bausch Site 113 - Kansas City
- Bausch Site 111 - St Louis
Alabama
- Bausch Site 124 - Birmingham
Arizona
- Bausch Site 125 - Scottsdale
Connecticut
- Bausch Site 127 - Danbury
Illinois
- Bausch Site 108 - Lake Villa
Indiana
- Bausch Site 112 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2022-01-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04140227
The ClinicalTrials.gov registry entry for NCT04140227 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 406-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (37% lower). The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dry Eye Disease (DED) appearing as the primary indexed condition, and to 1 intervention - of which NOV03 is the first listed.
NCT04140227 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT04140227 about?
NCT04140227 is a clinical study titled "Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)". The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyl...
What is the current status of trial NCT04140227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2020-09-24. Estimated completion is 2022-01-05.
What conditions does trial NCT04140227 study?
This clinical trial studies the following conditions: Dry Eye Disease (DED).
What interventions are being tested in trial NCT04140227?
The interventions under investigation include: NOV03 (DRUG).
Who is sponsoring clinical trial NCT04140227?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04140227 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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