Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
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)
1 other identifier
interventional
336
1 country
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
January 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedResults Posted
Study results publicly available
May 24, 2021
CompletedJanuary 4, 2022
October 1, 2019
5 months
November 2, 2017
April 30, 2021
December 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
NOV03 4 times daily (QID)
EXPERIMENTALPerfluorohexyloctance solution 4 times daily (QID)
NOV03 2 times daily (BID)
EXPERIMENTALPerfluorohexyloctance solution 2 times daily (BID)
Placebo 4 times daily (QID)
PLACEBO COMPARATORSaline solution (0.9% sodium chloride solution) 4 times daily (QID)
Placebo 2 times daily (BID)
PLACEBO COMPARATORSaline solution (0.9% sodium chloride solution) 2 times daily (BID)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novaliq GmbHlead
Study Sites (11)
Investigational site
Artesia, California, 90701, United States
Investigational Site
Newport Beach, California, 92660, United States
Investigational Site
Newport Beach, California, 92663, United States
Investigational Site
Santa Ana, California, 92705, United States
Investigational Site
Torrance, California, 90505, United States
Investigational site
Jacksonville, Florida, 32256, United States
Investigational Site
Lake Villa, Illinois, 60046, United States
Investigational Site
Kansas City, Missouri, 64111, United States
Investigational Site
Pennington, New Jersey, 08534, United States
Investigational Site
Nashville, Tennessee, 37205, United States
Investigational Site
Nashville, Tennessee, 37215, United States
Related Publications (1)
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.
PMID: 33369937RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonja Kroesser
- Organization
- Novaliq GmbH
Study Officials
- STUDY DIRECTOR
Sonja Kroesser, PhD
Novaliq GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2017
First Posted
November 6, 2017
Study Start
January 3, 2018
Primary Completion
May 18, 2018
Study Completion
July 27, 2018
Last Updated
January 4, 2022
Results First Posted
May 24, 2021
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share