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

Phase 2

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: Cyclosporine A
Drug: Placebo

Registration Number: NCT02617667

Lead Sponsor: Novaliq GmbH

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 207

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CyclASol Ophthalmic Solution 2	Cyclosporine A	Cyclosporine A solution (dose-level 2) in vehicle
CyclASol Ophthalmic Solution 1	Cyclosporine A	Cyclosporine A solution (dose-level 1) in vehicle
Restasis	Cyclosporine A	Cyclosporine A 0.05% ophthalmic emulsion
Placebo Ophthalmic Solution	Placebo	Vehicle only

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days	Baseline to 113 Days	The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.
Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days	Baseline to 113 Days	The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".

Secondary Outcome Measures