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)
Overview
- Phase
- Phase 3
- Intervention
- NOV03
- Conditions
- Dry Eye Disease
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 620
- Locations
- 35
- Primary Endpoint
- Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Was at least 18 years of age at the time of consent.
- •Provided written informed consent.
- •Had a subject-reported history of DED in both eyes for at least 6 months prior to Visit
- •Had a TFBUT ≤5 seconds at Visit 0 and Visit
- •Had an OSDI score ≥25 at Visit 0 and Visit
- •Had an unanesthetized Schirmer's test I score ≥5 mm at Visit 0 and Visit
- •Had MGD defined as total MGD score ≥3 at Visit 0 and Visit 1 (secretion of 5 central glands on the lower eyelid was evaluated, and each was scored from 0-3: 0 = normal; 1 = thick/yellow, whitish, particulate; 2 = paste; 3 = none/occluded). Total score ranged from 0-
- •Had a tCFS score between 4 and 11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the NEI scale at Visit 0 and Visit
- •Had at least one eye (the same eye) that satisfied all criteria for 4, 6, 7, and 8 above at Visit 0 and Visit
- •Was able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion Criteria
- •A subject was excluded from participating in the study if he or she met any of the following criteria:
- •Had been randomized in NVU-002 or NVU-003 study or had participated in the NVU-004 open-label extension (OLE) study.
- •Had any clinically significant ocular surface slit-lamp findings at Visit 0 and Visit 1 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including eye trauma or history of eye trauma or anterior membrane dystrophy.
- •Had a history of Stevens-Johnson syndrome.
- •Had active blepharitis or lid margin inflammation that required any topical antibiotics or topical steroids within last 30 days prior to Visit 0 or would have likely required such treatment during the trial. Any other lid margin therapy such as lid scrubs, lid wipes, warm compresses, systemic antibiotics (such as tetracyclines) and oral supplements for treatment of ocular conditions had to be stable within the last 30 days prior to Visit 1 and was to be maintained throughout the trial.
- •Had had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit
- •Had abnormal lid anatomy that caused incomplete eyelid closure, including entropion and ectropion, or floppy lid syndrome that exposed parts of the conjunctiva or impaired the blinking function of the eye.
- •Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 1 or was expected to receive a punctum plug or removal of a punctum plug, or had a punctum plug expected to be dissolved during the trial.
- •Had DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
- •Had an ocular or periocular malignancy.
Arms & Interventions
NOV03
100% perfluorohexyloctane 4 times daily (QID)
Intervention: NOV03
Saline solution
0.6% sodium chloride solution 4 times daily (QID)
Intervention: Saline Solution
Outcomes
Primary Outcomes
Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57
Time Frame: Assessed at 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: Assessed at 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 Outcomes
- Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15(Assessed at Day 15)
- Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15(Assessed at Day 15)
- Change From Baseline in Central Corneal Fluorescein Staining (NEI Scale) at Day 57(Assessed at Day 57)
- Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57(Assessed at Day 57)