CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

Dry Eye Disease (DED) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523142
• Other study ID #: CYS-005
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2021
• Est. completion date: May 23, 2022

Study information

• Verified date: August 2023
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 23, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• CyclASol Ophthalmic Solution
Cyclosporine A solution in vehicle

Locations

Country	Name	City	State
United States	CYS-005 Investigational Site	Andover	Massachusetts
United States	CYS-005 Investigational Site	Carmel	Indiana
United States	CYS-005 Investigational Site	Cranberry Township	Pennsylvania
United States	CYS-005 Investigational Site	Fargo	North Dakota
United States	CYS-005 Investigational Site	Henderson	Nevada
United States	CYS-005 Investigational Site	Layton	Utah
United States	CYS-005 Investigational Site	Los Angeles	California
United States	CYS-005 Investigational Site	Louisville	Kentucky
United States	CYS-005 Investigational Site	Lynchburg	Virginia
United States	CYS-005 Investigational Site	Memphis	Tennessee
United States	CYS-005 Investigational Site	Newport Beach	California
United States	CYS-005 Investigational Site	Raleigh	North Carolina
United States	CYS-005 Investigtional Site	Raynham	Massachusetts
United States	CYS-005 Investigational Site	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Any Adverse Events	An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.	12 months