Dry Eye Disease (DED)
Conditions
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.
Interventions
DRUGCyclASol Ophthalmic Solution
Cyclosporine A solution in vehicle
Sponsors
Novaliq GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Single arm, open label
Participants by arm
| Arm | Count |
|---|---|
| CyclASol Ophthalmic Solution Cyclosporine A solution in vehicle
CyclASol Ophthalmic Solution: Cyclosporine A solution in vehicle | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | CyclASol Ophthalmic Solution |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 14.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 175 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 153 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 148 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 13 / 200 |
| serious Total, serious adverse events | 4 / 200 |
Outcome results
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.
Time frame: 12 months
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CyclASol Ophthalmic Solution | Number of Subjects Reporting Any Adverse Events | 97 Participants |