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

Novaliq

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease (DED)

Treatments: Drug: NOV03; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03333057

NVU-002 (SEECASE)

Details and patient eligibility

About

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).

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 4 patient groups, including a placebo group

NOV03 4 times daily (QID)

Experimental group

Description:

Perfluorohexyloctance solution 4 times daily (QID)

Treatment:

Drug: NOV03

NOV03 2 times daily (BID)

Experimental group

Description:

Perfluorohexyloctance solution 2 times daily (BID)

Treatment:

Drug: NOV03

Placebo 4 times daily (QID)

Placebo Comparator group

Description:

Saline solution (0.9% sodium chloride solution) 4 times daily (QID)

Treatment:

Drug: Placebo

Placebo 2 times daily (BID)

Placebo Comparator group

Description:

Saline solution (0.9% sodium chloride solution) 2 times daily (BID)

Treatment:

Drug: Placebo