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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: CyclASol Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90013
      • CYS-005 Investigational Site
    • Newport Beach, California, United States, 92663
      • CYS-005 Investigational Site
  • Indiana
    • Carmel, Indiana, United States, 46290
      • CYS-005 Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • CYS-005 Investigational Site
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • CYS-005 Investigational Site
    • Raynham, Massachusetts, United States, 02767
      • CYS-005 Investigtional Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • CYS-005 Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • CYS-005 Investigational Site
    • Shelby, North Carolina, United States, 28150
      • CYS-005 Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • CYS-005 Investigational Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • CYS-005 Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • CYS-005 Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • CYS-005 Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • CYS-005 Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CyclASol Ophthalmic Solution; Cyclosporine A solution in vehicle	Drug: CyclASol Ophthalmic Solution; Cyclosporine A solution in vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Sonja Kroesser, PhD, Novaliq GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CYS-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No