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Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

Primary Purpose

Dry Eye Disease (DED)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NOV03
Placebo
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 (DED)

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 124
  • Bausch Site 125
  • Bausch Site 110
  • Bausch Site 121
  • Bausch Site 102
  • Bausch Site 101
  • Bausch Site 116
  • 103
  • Bausch Site 123
  • Bausch Site 127
  • Bausch Site 129
  • Bausch Site 115
  • Bausch Site 106
  • Bausch Site 117
  • Bausch Site 108
  • Bausch Site 112
  • Bausch Site 119
  • Bausch Site 126
  • Bausch Site 113
  • Bausch Site 111
  • Bausch Site 128
  • Bausch Site 114
  • Bausch Site 122
  • Bausch Site 107
  • Bausch Site 109
  • Bausch Site 120
  • Bausch Site 104
  • Bausch Site 105
  • Bausch Site 118

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NOV03 4 times daily (QID)

Placebo 4 times daily (QID)

Arm Description

100% Perfluorohexyloctance solution 4 times daily (QID)

Saline solution (0.6% sodium chloride solution) 4 times daily (QID)

Outcomes

Primary Outcome Measures

Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at 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
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
March 11, 2022
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04139798
Brief Title
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 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

5. Study Description

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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NOV03 4 times daily (QID)
Arm Type
Experimental
Arm Description
100% Perfluorohexyloctance solution 4 times daily (QID)
Arm Title
Placebo 4 times daily (QID)
Arm Type
Placebo Comparator
Arm Description
Saline solution (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)
Placebo
Intervention Description
Saline solution (0.6% sodium chloride solution)
Primary Outcome Measure Information:
Title
Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at Day 57
Description
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.
Time Frame
Baseline to Day 57
Title
CFB of Dryness Score at Day 57
Description
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Time Frame
Baseline to 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
Johnson Varughese
Organizational Affiliation
Bausch Health
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 124
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Bausch Site 125
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Bausch Site 110
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Bausch Site 121
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Bausch Site 102
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Bausch Site 101
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Bausch Site 116
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
103
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Bausch Site 123
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Bausch Site 127
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Bausch Site 129
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Bausch Site 115
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Bausch Site 106
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Bausch Site 117
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Bausch Site 108
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Bausch Site 112
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Bausch Site 119
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Bausch Site 126
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Bausch Site 113
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Bausch Site 111
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Bausch Site 128
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Bausch Site 114
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Bausch Site 122
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Bausch Site 107
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Bausch Site 109
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Bausch Site 120
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Bausch Site 104
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Bausch Site 105
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Bausch Site 118
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

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