Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

Study Overview
=================
Brief Summary
-----------------
The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).

Official Title
-----------------
A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: NOV03
* Drug: Saline Solution


Participation Criteria
=================
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 and Visit 1 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOV03<br>100% perfluorohexyloctane 4 times daily (QID) | Drug: NOV03<br>* 100% perfluorohexyloctane<br>|
| Placebo Comparator: Saline solution<br>0.6% sodium chloride solution 4 times daily (QID) | Drug: Saline Solution<br>* 0.6% sodium chloride solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section). | Baseline, Day 57 | 
| Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to no dryness and 100% corresponds to maximal dryness). | Baseline, Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 15 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to no dryness and 100% corresponds to maximal dryness). | Baseline, Day 15 | 
| Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 15 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section). | Baseline, Day 15 | 
| Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at Day 57 | Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to no discomfort and 100% corresponds to maximal discomfort). | Baseline, Day 57 | 
| Change from baseline in central Corneal Fluorescein Staining (NEI scale) at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section. | Baseline, Day 57 |