Corneal Edema
Conditions
Keywords
Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
Brief summary
Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.
Interventions
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older 2. Documented diagnosis of FCD 3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s) 4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)
Exclusion criteria
1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period 2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation 3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Corneal Thickness (CCT) | Baseline & 4 weeks | Mean change from baseline in CCT by ultrasound pachymetry |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at 12 clinic sites in the United States between September 2020 and June 2021.
Pre-assignment details
All participants underwent a washout of their pre-study treatment for Fuchs Corneal Dystrophy for a period of 24 hours prior to the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| Once Daily Netarsudil Ophthalmic Solution One drop of study artificial tear in the study eye in the morning, and one drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution | 20 |
| Twice Daily Netarsudil Ophthalmic Solution One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.
Netarsudil Ophthalmic: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study Completion | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | Once Daily Netarsudil Ophthalmic Solution | Twice Daily Netarsudil Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized Black/African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 18 Participants | 38 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 5 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 1 / 20 |
Outcome results
Primary
Central Corneal Thickness (CCT)
Mean change from baseline in CCT by ultrasound pachymetry
Time frame: Baseline & 4 weeks
Population: Modified Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Once Daily Netarsudil Ophthalmic Solution | Central Corneal Thickness (CCT) | -28.4 µm | Standard Deviation 35.72 |
| Twice Daily Netarsudil Ophthalmic Solution | Central Corneal Thickness (CCT) | -20.1 µm | Standard Deviation 39.12 |
Comparison: The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).p-value: 0.0021One-sample t-test (within group)