Clinical trial NCT04523142: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Official title: A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease (DED)
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Detailed description: Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.

Eligibility criteria: Inclusion Criteria:

* Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
* Signed ICF (Informed Consent Form)
* Subject-reported history of DED in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Early termination of CYS-004
* Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
* Have a history of herpetic keratitis;
* Have an ocular or periocular malignancy;
* Be unwilling to avoid wearing contact lenses during the trial;
* Have any planned ocular or eyelid surgeries during the trial period
* Be a woman who is pregnant, nursing or planning a pregnancy
* Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
* Women of childbearing potential not using an acceptable means of contraception
* Presence of known allergy and/or sensitivity to the study drug or its components
* Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
* Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly

Primary outcomes:
measure: Number of Subjects Reporting Any Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: CYS-005 Investigational Site
state: California
city: Newport Beach
country: United States
facility: CYS-005 Investigational Site
state: California
city: Carmel
country: United States
facility: CYS-005 Investigational Site
state: Indiana
city: Louisville
country: United States
facility: CYS-005 Investigational Site
state: Kentucky
city: Andover
country: United States
facility: CYS-005 Investigational Site
state: Massachusetts
city: Raynham
country: United States
facility: CYS-005 Investigtional Site
state: Massachusetts
city: Henderson
country: United States
facility: CYS-005 Investigational Site
state: Nevada
city: Raleigh
country: United States
facility: CYS-005 Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: CYS-005 Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: CYS-005 Investigational Site
state: North Dakota
city: Cranberry Township
country: United States
facility: CYS-005 Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: CYS-005 Investigational Site
state: Tennessee
city: Layton
country: United States
facility: CYS-005 Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: CYS-005 Investigational Site
state: Virginia
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, PhD
role: STUDY_DIRECTOR
References: