Trial record 1 of 1 for:
nov03 + mojave
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
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| ClinicalTrials.gov Identifier: NCT04567329 |
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Recruitment Status :
Completed
First Posted : September 28, 2020
Last Update Posted : May 11, 2022
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Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
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Brief Summary:
The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Disease | Drug: NOV03 Drug: Saline Solution | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 622 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study) |
| Actual Study Start Date : | November 18, 2020 |
| Actual Primary Completion Date : | August 30, 2021 |
| Actual Study Completion Date : | August 30, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sodium chloride
| Arm | Intervention/treatment |
|---|---|
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Experimental: NOV03
100% perfluorohexyloctane 4 times daily (QID)
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Drug: NOV03
100% perfluorohexyloctane |
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Placebo Comparator: Saline solution
0.6% sodium chloride solution 4 times daily (QID)
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Drug: Saline Solution
0.6% sodium chloride solution |
Primary Outcome Measures :
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 [ Time Frame: Baseline, Day 57 ]The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
- Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 [ Time Frame: Baseline, Day 57 ]Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Secondary Outcome Measures :
- Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 15 [ Time Frame: Baseline, Day 15 ]Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 15 [ Time Frame: Baseline, Day 15 ]The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section).
- Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at Day 57 [ Time Frame: Baseline, Day 57 ]Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no discomfort" and 100% corresponds to "maximal discomfort").
- Change from baseline in central Corneal Fluorescein Staining (NEI scale) at Day 57 [ Time Frame: Baseline, Day 57 ]The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 and Visit 1
- 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
Information from the National Library of Medicine
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): NCT04567329
Locations
Show 28 study locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Daniel Donatello | Bausch & Lomb Incorporated |
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT04567329 |
| Other Study ID Numbers: |
904 |
| First Posted: | September 28, 2020 Key Record Dates |
| Last Update Posted: | May 11, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Meibomian Gland Dysfunction Lacrimal Apparatus Diseases Keratoconjunctivitis |
Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Eyelid Diseases |