Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
Public ClinicalTrials.gov record NCT04140227. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-Center, Open-Label, Single-Arm Extension Clinical Trial to Assess the Extended Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04140227
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 256 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2020 (Actual)
- Primary completion
- Jan 5, 2022 (Actual)
- Completion
- Jan 5, 2022 (Actual)
- Last update posted
- Mar 4, 2024
2020 – 2022
United States locations
- U.S. sites
- 28
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bausch Site 124 | Birmingham | Alabama | 35233 | — |
| Bausch Site 125 | Scottsdale | Arizona | 85254 | — |
| Bausch Site 110 | Glendale | California | 91204 | — |
| Bausch Site 121 | Long Beach | California | 90805 | — |
| Bausch Site 102 | Mission Hills | California | 91345 | — |
| Bausch Site 101 | Newport Beach | California | 92663 | — |
| Bausch Site 116 | Rancho Cordova | California | 95670 | — |
| Bausch Site 103 | Torrance | California | 90505 | — |
| Bausch Site 123 | Torrance | California | 90505 | — |
| Bausch Site 127 | Danbury | Connecticut | 06810 | — |
| Bausch Site 129 | Fort Myers | Florida | 33901 | — |
| Bausch Site 115 | Jacksonville | Florida | 32256 | — |
| Bausch Site 106 | Largo | Florida | 33773 | — |
| Bausch Site 117 | Tampa | Florida | 33603 | — |
| Bausch Site 108 | Lake Villa | Illinois | 60046 | — |
| Bausch Site 112 | Indianapolis | Indiana | 46260 | — |
| Bausch Site 119 | Edgewood | Kentucky | 41017 | — |
| Bausch Site 126 | Winchester | Massachusetts | 01890 | — |
| Bausch Site 113 | Kansas City | Missouri | 64111 | — |
| Bausch Site 111 | St Louis | Missouri | 63131 | — |
| Bausch Site 128 | Slingerlands | New York | 12159 | — |
| Bausch Site 114 | Raleigh | North Carolina | 27603 | — |
| Bausch Site 122 | Cranberry Township | Pennsylvania | 16066 | — |
| Bausch Site 107 | Memphis | Tennessee | 38119 | — |
| Bausch Site 109 | Nashville | Tennessee | 37205 | — |
| Bausch Site 120 | El Paso | Texas | 79902 | — |
| Bausch Site 104 | Lakeway | Texas | 78738 | — |
| Bausch Site 118 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04140227, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04140227 live on ClinicalTrials.gov.