Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
NCT ID: NCT03333057
Last Updated: 2022-01-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
336 participants
INTERVENTIONAL
2018-01-03
2018-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
NCT04139798
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
NCT04140227
A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
NCT07025811
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
NCT04521465
Effects of NOV03 on the Tear Film
NCT05723770
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NOV03 4 times daily (QID)
Perfluorohexyloctance solution 4 times daily (QID)
NOV03
Perfluorohexyloctane
NOV03 2 times daily (BID)
Perfluorohexyloctance solution 2 times daily (BID)
NOV03
Perfluorohexyloctane
Placebo 4 times daily (QID)
Saline solution (0.9% sodium chloride solution) 4 times daily (QID)
Placebo
Saline solution (0.9% sodium chloride solution)
Placebo 2 times daily (BID)
Saline solution (0.9% sodium chloride solution) 2 times daily (BID)
Placebo
Saline solution (0.9% sodium chloride solution)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NOV03
Perfluorohexyloctane
Placebo
Saline solution (0.9% sodium chloride solution)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novaliq GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sonja Kroesser, PhD
Role: STUDY_DIRECTOR
Novaliq GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational site
Artesia, California, United States
Investigational Site
Newport Beach, California, United States
Investigational Site
Newport Beach, California, United States
Investigational Site
Santa Ana, California, United States
Investigational Site
Torrance, California, United States
Investigational site
Jacksonville, Florida, United States
Investigational Site
Lake Villa, Illinois, United States
Investigational Site
Kansas City, Missouri, United States
Investigational Site
Pennington, New Jersey, United States
Investigational Site
Nashville, Tennessee, United States
Investigational Site
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krosser S; SEECASE study group. A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease. Cornea. 2021 Sep 1;40(9):1132-1140. doi: 10.1097/ICO.0000000000002622.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Publication of Study Results in Cornea
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NVU-002 (SEECASE)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.