We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NOV03 + gobi
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04139798
Recruitment Status : Completed
First Posted : October 25, 2019
Last Update Posted : March 16, 2022
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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).

Condition or disease Intervention/treatment Phase
Dry Eye Disease (DED) Drug: NOV03 Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 599 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 20, 2020
Actual Primary Completion Date : March 12, 2021
Actual Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
Drug: NOV03
100% Perfluorohexyloctane

Placebo Comparator: Placebo 4 times daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Drug: Placebo
Saline solution (0.6% sodium chloride solution)

Primary Outcome Measures :
  1. Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at Day 57 [ Time Frame: Baseline to 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.

  2. CFB of Dryness Score at Day 57 [ Time Frame: Baseline to 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139798

Show Show 29 study locations
Sponsors and Collaborators
Bausch & Lomb Incorporated
Layout table for investigator information
Study Director: Johnson Varughese Bausch Health
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT04139798    
Other Study ID Numbers: NVU-003 (Gobi)
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Conjunctival Diseases
Corneal Diseases
Eyelid Diseases