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Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

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ClinicalTrials.gov Identifier: NCT03333057
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Novaliq GmbH

Brief Summary:
This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).

Condition or disease Intervention/treatment Phase
Dry Eye Disease (DED) Drug: NOV03 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Masked, Saline-Controlled Study to Evaluate the Effect of Perfluorohexyloctane (NOV03) at Two Different Dosing Regimens on Signs and Symptoms of Dry Eye Disease (DED)
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

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

Experimental: NOV03 2 times daily (BID)
100%Perfluorohexyloctance solution 2 times daily (BID)
Drug: NOV03
100% Perfluorohexyloctane

Placebo Comparator: Placebo 4 times daily (QID)
Saline solution (0.9% sodium chloride solution) 4 times daily (QID)
Drug: Placebo
Saline solution (0.9% sodium chloride solution)

Placebo Comparator: Placebo 2 times daily (BID)
Saline solution (0.9% sodium chloride solution) 2 times daily (BID)
Drug: Placebo
Saline solution (0.9% sodium chloride solution)




Primary Outcome Measures :
  1. Corneal Fluorescein Staining (CFS) total (NEI grading) [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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): NCT03333057


Locations
United States, California
Investigational site
Artesia, California, United States, 90701
Investigational Site
Newport Beach, California, United States, 92660
Investigational Site
Newport Beach, California, United States, 92663
Investigational Site
Santa Ana, California, United States, 92705
Investigational Site
Torrance, California, United States, 90505
United States, Florida
Investigational site
Jacksonville, Florida, United States, 32256
United States, Illinois
Investigational Site
Lake Villa, Illinois, United States, 60046
United States, Missouri
Investigational Site
Kansas City, Missouri, United States, 64111
United States, New Jersey
Investigational Site
Pennington, New Jersey, United States, 08534
United States, Tennessee
Investigational Site
Nashville, Tennessee, United States, 37205
Investigational Site
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Novaliq GmbH

Responsible Party: Novaliq GmbH
ClinicalTrials.gov Identifier: NCT03333057     History of Changes
Other Study ID Numbers: NVU-002 (SEECASE)
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Signs and Symptoms
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases