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

Phase 3

Completed

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: CyclASol Ophthalmic Solution

• Registration Number: NCT04523142
• Lead Sponsor: Novaliq GmbH

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.

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2021-01-04
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-23
• Disposition First Submitted: 2022-12-07
• Results First Submitted: 2023-07-20
• Status Verified: 2023-08
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2023-10-16
• Disposition First Posted: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyclASol Ophthalmic Solution	CyclASol Ophthalmic Solution	Cyclosporine A solution in vehicle

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Any Adverse Events	12 months	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.

Trial Locations

Locations (2)

CYS-005 Investigtional Site; 🇺🇸 Raynham, Massachusetts, United States

CYS-005 Investigational Site; 🇺🇸 Lynchburg, Virginia, United States