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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Dry Eye Disease (DED)

Intervention / Treatment
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* Drug: NOV03
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOV03 4 times daily (QID)<br>Perfluorohexyloctance solution 4 times daily (QID) | Drug: NOV03<br>* Perfluorohexyloctane<br>|
| Experimental: NOV03 2 times daily (BID)<br>Perfluorohexyloctance solution 2 times daily (BID) | Drug: NOV03<br>* Perfluorohexyloctane<br>|
| Placebo Comparator: Placebo 4 times daily (QID)<br>Saline solution (0.9% sodium chloride solution) 4 times daily (QID) | Drug: Placebo<br>* Saline solution (0.9% sodium chloride solution)<br>|
| Placebo Comparator: Placebo 2 times daily (BID)<br>Saline solution (0.9% sodium chloride solution) 2 times daily (BID) | Drug: Placebo<br>* Saline solution (0.9% sodium chloride solution)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |