Dry Eye Disease, Endothelial Cell
Conditions
Brief summary
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
Detailed description
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
Interventions
DRUGCyclosporine ophthalmic solution, 0.1%
Colorless and clear opthalmic solution containing 0.1% Cyclosporine
DRUGSaline solution, 0.6%
Colorless and clear sodium chloride solution (0.6%)
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
* Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye disease (DED) in both eyes * Be able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion criteria
* Be a woman who is pregnant, nursing, or planning a pregnancy; * Unwillingness to to use acceptable means of birth control * Clinically significant slit-lamp findings or abnormal lid anatomy at screening * Ongoing ocular or systemic infection at screening or baseline * Presence of uncontrolled systemic diseases * Presence of known allergy and/or sensitivity to the study drug or its components * Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period * Have a condition or be in a situation 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. * Randomized in a previous CyclASol trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corneal Endothelial Cell Density (ECD) | 12 months | Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye |
Countries
United States
Contacts
STUDY_DIRECTORSonja Krösser, PhD
Novaliq GmbH
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants |
| Corneal Endothelial Cell Density | 2507.7 cell/mm² STANDARD_DEVIATION 250.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 204 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 69 |
| other Total, other adverse events | 27 / 135 | 13 / 69 |
| serious Total, serious adverse events | 5 / 135 | 2 / 69 |
Outcome results
None listed