Trial record 1 of 1 for:
NOV03 + gobi
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
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| ClinicalTrials.gov Identifier: NCT04139798 |
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Recruitment Status :
Completed
First Posted : October 25, 2019
Last Update Posted : March 16, 2022
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Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
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Brief Summary:
This trial will evaluate 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 (DED) | Drug: NOV03 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 599 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 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study) |
| Actual Study Start Date : | July 20, 2020 |
| Actual Primary Completion Date : | March 12, 2021 |
| Actual Study Completion Date : | March 12, 2021 |
Resource links provided by the National Library of Medicine
| 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 |
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Placebo Comparator: Placebo 4 times daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
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Drug: Placebo
Saline solution (0.6% sodium chloride solution) |
Primary Outcome Measures :
- Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at Day 57 [ Time Frame: Baseline to Day 57 ]Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
- CFB of Dryness Score at Day 57 [ Time Frame: Baseline to Day 57 ]Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Information from the National Library of Medicine
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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): NCT04139798
Locations
Show 29 study locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Johnson Varughese | Bausch Health |
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT04139798 |
| Other Study ID Numbers: |
NVU-003 (Gobi) |
| First Posted: | October 25, 2019 Key Record Dates |
| Last Update Posted: | March 16, 2022 |
| Last Verified: | March 2022 |
| 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 |