Clinical trial NCT02617667: CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Official title: A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days
timeFrame: Baseline to 113 Days
measure: Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days
timeFrame: Baseline to 113 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: CYS-002 Investigational Site
state: California
city: Lewiston
country: United States
facility: CYS-002 Investigational Site
state: Maine
city: Andover
country: United States
facility: CYS-002 Investigational Site
state: Massachusetts
city: Quincy
country: United States
facility: CYS-002 Investigational Site
state: Massachusetts
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, Dr.sc.hum.
role: STUDY_DIRECTOR
References:
citation: Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GW, Steven P, Krosser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800. doi: 10.1016/j.ophtha.2019.01.024. Epub 2019 Jan 28.