Skip to main content
OpenTrials
Completed

NCT Number: NCT04139798

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch Site 124, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOV03

Drug

100% Perfluorohexyloctane

Placebo

Drug

Saline solution (0.6% sodium chloride solution)

Primary outcomes

  1. Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57

    Time frame: Assessed from 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. Change From Baseline of Dryness Score at Day 57

    Time frame: Assessed from 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).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2019
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.