ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

Novaliq

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: CyclASol topical ocular, eye drops; Drug: Vehicle topical ocular, eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT04523129

CYS-004

Details and patient eligibility

About

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Full description

This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Enrollment: 834 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed ICF (Informed Consent Form)
• Patient-reported history of DED in both eyes
• Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
• Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion criteria

• Women who are pregnant, nursing or planning a pregnancy
• Unwillingness to submit a urine 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/periocular malignancy
• History of herpetic keratitis
• Active ocular allergies or ocular allergies that may become active during the study period
• Ongoing ocular or systemic infection at screening or baseline
• Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
• Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
• Intraocular surgery or ocular laser surgery within the previous 6 months, or have any 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 its components
• Randomized in a previous CyclASol trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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834 participants in 2 patient groups, including a placebo group

CyclASol Ophthalmic Solution

Experimental group

Description:

Cyclosporine A solution in vehicle

Treatment:

Drug: CyclASol topical ocular, eye drops

Vehicle Ophthalmic solution

Placebo Comparator group

Description:

Vehicle only

Treatment:

Drug: Vehicle topical ocular, eye drops