At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 256 enrolled
Drug / intervention
NOV03drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating NOV03 for Dry Eye Disease (DED). Completed, enrolled 256 participants across 28 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease (DED)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartSep 2020
Primary CompletionJan 2022
TodayJul 2026
First PostedOct 25, 2019
Enrollment StartSep 24, 2020
Primary CompletionJan 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.7 years ago
Interventions
NOV03drug
100% Perfluorohexyloctane