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

Phase 2

Completed

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: NOV03; Drug: Placebo

• Registration Number: NCT03333057
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-01-03
• Primary Completion: 2018-05-18
• Study Completion: 2018-07-27
• Disposition First Submitted: 2019-06-07
• Disposition First Submitted QC: 2019-06-07
• Disposition First Posted: 2019-06-10
• Status Verified: 2019-10
• Results First Submitted: 2021-04-30
• Results First Submitted QC: 2021-04-30
• Results First Posted: 2021-05-24
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOV03 4 times daily (QID)	NOV03	Perfluorohexyloctance solution 4 times daily (QID)
NOV03 2 times daily (BID)	NOV03	Perfluorohexyloctance solution 2 times daily (BID)
Placebo 4 times daily (QID)	Placebo	Saline solution (0.9% sodium chloride solution) 4 times daily (QID)
Placebo 2 times daily (BID)	Placebo	Saline solution (0.9% sodium chloride solution) 2 times daily (BID)

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)	baseline and 2 months	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.

Trial Locations

Locations (2)

Investigational site; 🇺🇸 Jacksonville, Florida, United States

Investigational Site; 🇺🇸 Nashville, Tennessee, United States