Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

NCT04567329 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 904
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 35

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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye 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).

  Assessed at Day 57

• Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) 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").

  Assessed at Day 57

Secondary Outcomes (4)

• Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15

  Assessed at Day 15

• Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15

  Assessed at Day 15

• Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57

  Assessed at Day 57

• Change From Baseline in Central Corneal Fluorescein Staining (NEI Scale) at Day 57

  Assessed at Day 57

Study Arms (2)

NOV03

EXPERIMENTAL

100% perfluorohexyloctane 4 times daily (QID)

Drug: NOV03

Saline solution

PLACEBO COMPARATOR

0.6% sodium chloride solution 4 times daily (QID)

Drug: Saline Solution

Interventions

NOV03 DRUG

100% perfluorohexyloctane

NOV03

Saline Solution DRUG

0.6% sodium chloride solution

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0.
• Had a TFBUT ≤5 seconds at Visit 0 and Visit 1.
• Had an OSDI score ≥25 at Visit 0 and Visit 1.
• Had an unanesthetized Schirmer's test I score ≥5 mm at Visit 0 and Visit 1.
• 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 0-15.
• 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 1.
• Had at least one eye (the same eye) that satisfied all criteria for 4, 6, 7, and 8 above at Visit 0 and Visit 1.
• Was able and willing to follow instructions, including participation in all trial assessments and visits.

You may not qualify if:

• 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 1.
• 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.
• Had a corneal epithelial defect or had significant confluent staining or filaments anywhere on the cornea.
• Had a history of herpetic keratitis.
• Had active ocular allergies or ocular allergies that were expected to be active during the trial period.
• Was diagnosed with an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
• Had worn contact lenses within 1 month of Visit 0 or anticipated using contact lenses during the trial.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (35)

Bausch Site 206

Phoenix, Arizona, 85032, United States

Location

Bausch Site 202

Garden Grove, California, 92843, United States

Location

Bausch Site 221

Hemet, California, 92545, United States

Location

Bausch Site 214

Inglewood, California, 90301, United States

Location

Bausch Site 226

Murrieta, California, 92562, United States

Location

Bausch Site 213

Santa Ana, California, 92705, United States

Location

Bausch site 236

Westminster, California, 92683, United States

Location

Bausch site 225

Grand Junction, Colorado, 81501, United States

Location

Bausch Site 211

Delray Beach, Florida, 33484, United States

Location

Bausch Site 204

Morrow, Georgia, 30260, United States

Location

Bausch Site 209

Chicago, Illinois, 60616, United States

Location

Bausch site 218

Hoffman Estates, Illinois, 60169, United States

Location

Bausch Site 230

Overland Park, Kansas, 66210, United States

Location

Bausch Site 207

Louisville, Kentucky, 40220, United States

Location

Bausch Site 228

Havre de Grace, Maryland, 21078, United States

Location

Bausch Site 231

Bloomington, Minnesota, 55431, United States

Location

Bausch Site 229

St Louis, Missouri, 63128, United States

Location

Bausch Site 224

St Louis, Missouri, 63131, United States

Location

Bausch Site 217

Washington, Missouri, 63090, United States

Location

Bausch Site 208

Rochester, New York, 14618, United States

Location

Bausch Site 210

Asheville, North Carolina, 28803, United States

Location

Bausch site 233

High Point, North Carolina, 27262, United States

Location

Bausch site 232

Southern Pines, North Carolina, 28387, United States

Location

Bausch Site 201

Cincinnati, Ohio, 45247, United States

Location

Bausch Site 216

Cleveland, Ohio, 44115, United States

Location

Bausch Site 223

Columbus, Ohio, 43215, United States

Location

Bausch Site 215

Nashville, Tennessee, 37215, United States

Location

Bausch site 235

Austin, Texas, 78731, United States

Location

Bausch Site 219

Cedar Park, Texas, 78613, United States

Location

Bausch Site 212

League City, Texas, 77573, United States

Location

Bausch site 234

San Antonio, Texas, 78209, United States

Location

Bausch Site 222

San Antonio, Texas, 78215, United States

Location

Bausch Site 203

San Antonio, Texas, 78230, United States

Location

Bausch Site 220

Norfolk, Virginia, 23502, United States

Location

Bausch Site 227

Seattle, Washington, 98119, United States

Location

Related Publications (2)

• Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024.

  PMID: 39564145 DERIVED

• Sheppard JD, Kurata F, Epitropoulos AT, Krosser S, Vittitow JL; MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/j.ajo.2023.03.008. Epub 2023 Mar 21.

  PMID: 36948372 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Daniel Donatello
• Organization: Bausch & Lomb

Daniel.Donatello@bausch.com

5853385306

Study Officials

• Daniel Donatello

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: November 18, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-07

Locations

US (35)