Dry Eye Disease
Conditions
Brief summary
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
Detailed description
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.
Interventions
Cyclosporine A solution in vehicle
Vehicle
Sponsors
Novaliq GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act) * Patient-reported history of DED in both eyes * Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms * Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion criteria
* Women who are pregnant, nursing or planning a pregnancy * Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * Clinically significant slit-lamp findings or abnormal lid anatomy at screening * Ocular/periocular malignancy * History of herpetic keratitis * Active ocular allergies or ocular allergies that may become active during the study period * Ongoing ocular or systemic infection at screening or baseline * Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study * History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A or Liftigrast within 2 months prior to screening * Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period * Presence of uncontrolled systemic diseases * Presence of known allergy and/or sensitivity to the study drug or its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining at Day 29 | baseline and 1 month [day 29] | CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage. |
| Change From Baseline in Ocular Surface Disease Index at Day 29 | baseline and 1 month [day 29] | The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index. |
Countries
United States
Participant flow
Pre-assignment details
After a 2-week run-in period, eligible DED patients were randomized 1:1 to either CyclASol 0.1% or vehicle twice daily.
Participants by arm
| Arm | Count |
|---|---|
| CyclASol Ophthalmic Solution Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle | 162 |
| Vehicle Ophthalmic Solution Vehicle only
Vehicle topical ocular, eye drops: Vehicle | 166 |
| Total | 328 |
Baseline characteristics
| Characteristic | CyclASol Ophthalmic Solution | Total | Vehicle Ophthalmic Solution |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 13.6 | 61.4 years STANDARD_DEVIATION 13.11 | 61.3 years STANDARD_DEVIATION 12.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 26 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 147 Participants | 302 Participants | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 33 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 30 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 130 Participants | 257 Participants | 127 Participants |
| Region of Enrollment United States | 162 participants | 328 participants | 166 participants |
| Sex: Female, Male Female | 116 Participants | 235 Participants | 119 Participants |
| Sex: Female, Male Male | 46 Participants | 93 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 166 |
| other Total, other adverse events | 26 / 162 | 23 / 166 |
| serious Total, serious adverse events | 0 / 162 | 3 / 166 |
Outcome results
Primary
Change From Baseline in Ocular Surface Disease Index at Day 29
The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
Time frame: baseline and 1 month [day 29]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CyclASol Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index at Day 29 | -7.08 score on a scale | Standard Deviation 18.65 |
| Vehicle Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index at Day 29 | -5.37 score on a scale | Standard Deviation 15.291 |
Primary
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Time frame: baseline and 1 month [day 29]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CyclASol Ophthalmic Solution | Change From Baseline in Total Corneal Fluorescein Staining at Day 29 | -2.9 score on a scale | Standard Deviation 2.59 |
| Vehicle Ophthalmic Solution | Change From Baseline in Total Corneal Fluorescein Staining at Day 29 | -2.2 score on a scale | Standard Deviation 2.73 |