Clinical trial NCT03333057: Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease (DED)
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
timeFrame: baseline and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Investigational site
state: California
city: Newport Beach
country: United States
facility: Investigational Site
state: California
city: Newport Beach
country: United States
facility: Investigational Site
state: California
city: Santa Ana
country: United States
facility: Investigational Site
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Jacksonville
country: United States
facility: Investigational site
state: Florida
city: Lake Villa
country: United States
facility: Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: Pennington
country: United States
facility: Investigational Site
state: New Jersey
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, PhD
role: STUDY_DIRECTOR
References:
citation: 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.