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

Dry Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567329
• Other study ID #: 904
• Status: Completed
• Phase: Phase 3
• Start date: November 18, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2022
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Drug:
• NOV03
100% perfluorohexyloctane
• Saline Solution
0.6% sodium chloride solution

Locations

Country	Name	City	State
United States	Bausch Site 210	Asheville	North Carolina
United States	Bausch Site 231	Bloomington	Minnesota
United States	Bausch Site 219	Cedar Park	Texas
United States	Bausch Site 209	Chicago	Illinois
United States	Bausch Site 201	Cincinnati	Ohio
United States	Bausch Site 216	Cleveland	Ohio
United States	Bausch Site 223	Columbus	Ohio
United States	Bausch Site 211	Delray Beach	Florida
United States	Bausch Site 202	Garden Grove	California
United States	Bausch Site 228	Havre De Grace	Maryland
United States	Bausch Site 221	Hemet	California
United States	Bausch Site 214	Inglewood	California
United States	Bausch Site 212	League City	Texas
United States	Bausch Site 207	Louisville	Kentucky
United States	Bausch Site 226	Murrieta	California
United States	Bausch Site 215	Nashville	Tennessee
United States	Bausch Site 205	New York	New York
United States	Bausch Site 220	Norfolk	Virginia
United States	Bausch Site 230	Overland Park	Kansas
United States	Bausch Site 206	Phoenix	Arizona
United States	Bausch Site 208	Rochester	New York
United States	Bausch Site 224	Saint Louis	Missouri
United States	Bausch Site 229	Saint Louis	Missouri
United States	Bausch Site 203	San Antonio	Texas
United States	Bausch Site 222	San Antonio	Texas
United States	Bausch Site 213	Santa Ana	California
United States	Bausch Site 227	Seattle	Washington
United States	Bausch Site 217	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total Corneal Fluorescein Staining (NEI scale) 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).	Baseline, Day 57
Primary	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").	Baseline, Day 57
Secondary	Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at 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").	Baseline, Day 15
Secondary	Change from baseline in total Corneal Fluorescein Staining (NEI scale) at 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).	Baseline, Day 15
Secondary	Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at 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").	Baseline, Day 57
Secondary	Change from baseline in central Corneal Fluorescein Staining (NEI scale) 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 of 3 points in the central section.	Baseline, Day 57