Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
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| ClinicalTrials.gov Identifier: NCT04140227 |
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Recruitment Status :
Completed
First Posted : October 25, 2019
Results First Posted : December 29, 2023
Last Update Posted : March 4, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Disease (DED) | Drug: NOV03 | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 256 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | September 24, 2020 |
| Actual Primary Completion Date : | January 5, 2022 |
| Actual Study Completion Date : | January 5, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
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Drug: NOV03
100% Perfluorohexyloctane |
- Number of Participants With Ocular and Non-ocular Adverse Events [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed ICF (Informed Consent Form)
- Subject-reported history of Drye Eye Disease (DED) in both eyes
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria:
- Women who are pregnant, nursing or planning pregnancy
- Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
- Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- Ocular/peri-ocular malignancy
- History of herpetic keratitis
- Active ocular allergies or ocular allergies that are expected to be active during the study
- Ongoing ocular or systemic infection
- Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
- Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
- Presence of uncontrolled systemic diseases
- Presence of known allergy and/or sensitivity to the study drug or saline components
- Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140227
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| Study Director: | Johnson Varughese | Bausch Health |
Documents provided by Bausch & Lomb Incorporated:
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT04140227 |
| Other Study ID Numbers: |
NVU-004 (Kalahari) |
| First Posted: | October 25, 2019 Key Record Dates |
| Results First Posted: | December 29, 2023 |
| Last Update Posted: | March 4, 2024 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases |