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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NOV03
Saline Solution
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bausch Site 206
  • Bausch Site 202
  • Bausch Site 221
  • Bausch Site 214
  • Bausch Site 226
  • Bausch Site 213
  • Bausch Site 211
  • Bausch Site 209
  • Bausch Site 230
  • Bausch Site 207
  • Bausch Site 228
  • Bausch Site 231
  • Bausch Site 229
  • Bausch Site 224
  • Bausch Site 217
  • Bausch Site 205
  • Bausch Site 208
  • Bausch Site 210
  • Bausch Site 201
  • Bausch Site 216
  • Bausch Site 223
  • Bausch Site 215
  • Bausch Site 219
  • Bausch Site 212
  • Bausch Site 203
  • Bausch Site 222
  • Bausch Site 220
  • Bausch Site 227

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NOV03

Saline solution

Arm Description

100% perfluorohexyloctane 4 times daily (QID)

0.6% sodium chloride solution 4 times daily (QID)

Outcomes

Primary Outcome Measures

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).
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").

Secondary Outcome Measures

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").
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).
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").
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.

Full Information

First Posted
September 23, 2020
Last Updated
May 4, 2022
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04567329
Brief Title
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
622 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NOV03
Arm Type
Experimental
Arm Description
100% perfluorohexyloctane 4 times daily (QID)
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
0.6% sodium chloride solution 4 times daily (QID)
Intervention Type
Drug
Intervention Name(s)
NOV03
Intervention Description
100% perfluorohexyloctane
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
0.6% sodium chloride solution
Primary Outcome Measure Information:
Title
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
Description
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).
Time Frame
Baseline, Day 57
Title
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
Description
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").
Time Frame
Baseline, Day 57
Secondary Outcome Measure Information:
Title
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 15
Description
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").
Time Frame
Baseline, Day 15
Title
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 15
Description
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).
Time Frame
Baseline, Day 15
Title
Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at Day 57
Description
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").
Time Frame
Baseline, Day 57
Title
Change from baseline in central Corneal Fluorescein Staining (NEI scale) at Day 57
Description
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.
Time Frame
Baseline, Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Donatello
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 206
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Bausch Site 202
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Bausch Site 221
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Bausch Site 214
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Bausch Site 226
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Bausch Site 213
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Bausch Site 211
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Bausch Site 209
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Bausch Site 230
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Bausch Site 207
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Bausch Site 228
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Bausch Site 231
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Bausch Site 229
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Bausch Site 224
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Bausch Site 217
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Bausch Site 205
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Bausch Site 208
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Bausch Site 210
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Bausch Site 201
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Bausch Site 216
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Bausch Site 223
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Bausch Site 215
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Bausch Site 219
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Bausch Site 212
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Bausch Site 203
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Bausch Site 222
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Bausch Site 220
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bausch Site 227
City
Seattle
State/Province
Washington
ZIP/Postal Code
98119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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