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

Dry Eye Disease (DED) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333057
• Other study ID #: NVU-002 (SEECASE)
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2018
• Est. completion date: July 27, 2018

Study information

• Verified date: October 2019
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: July 27, 2018
• Est. primary completion date: May 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• NOV03
Perfluorohexyloctane
• Placebo
Saline solution (0.9% sodium chloride solution)

Locations

Country	Name	City	State
United States	Investigational site	Artesia	California
United States	Investigational site	Jacksonville	Florida
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Lake Villa	Illinois
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	Newport Beach	California
United States	Investigational Site	Newport Beach	California
United States	Investigational Site	Pennington	New Jersey
United States	Investigational Site	Santa Ana	California
United States	Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)	The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8; The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.	baseline and 2 months

External Links

•   Publication of Study Results in Cornea