CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

Novaliq

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: Placebo; Drug: Cyclosporine A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617667

CYS-002

Details and patient eligibility

About

The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).

Full description

This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included.

The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED.

The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

Enrollment: 207 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
• Patient-reported history of dry eye in both eyes
• Current use of over-the-counter and/or prescription eye drops 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 blood pregnancy test at screening and at 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
• DED secondary to scarring or ocular or periocular malignancy
• History of herpetic keratitis
• Active ocular allergies or ocular allergies that are expected to be 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
• History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
• Intra-ocular 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 an uncontrolled systemic disease
• Presence of a known allergy and/or sensitivity to the study drug or its components

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 4 patient groups, including a placebo group

CyclASol Ophthalmic Solution 1

Experimental group

Description:

Cyclosporine A solution (dose-level 1) in vehicle

Treatment:

Drug: Cyclosporine A

CyclASol Ophthalmic Solution 2

Experimental group

Description:

Cyclosporine A solution (dose-level 2) in vehicle

Treatment:

Drug: Cyclosporine A

Placebo Ophthalmic Solution

Placebo Comparator group

Description:

Vehicle only

Treatment:

Drug: Placebo

Restasis

Active Comparator group

Description:

Cyclosporine A 0.05% ophthalmic emulsion

Treatment:

Drug: Cyclosporine A