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

Study Overview
=================
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.

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

Conditions
-----------------
Dry Eye Disease (DED)

Intervention / Treatment
-----------------
* Drug: CyclASol Ophthalmic Solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyclASol Ophthalmic Solution<br>Cyclosporine A solution in vehicle | Drug: CyclASol Ophthalmic Solution<br>* Cyclosporine A solution in vehicle<br>|

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 |