Dry Eye
Conditions
Keywords
Dry Eye, Sjogrens, dry eye syndrome (DES), Keratoconjunctivitis sicca (KCS), keratitis, Xerophthalmia, Sjögren's Syndrome, Sjogren's Syndrome
Brief summary
The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.
Detailed description
Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1. * ECF843 0.45 mg/mL three times daily (TID) or vehicle * ECF843 0.15 mg/mL TID or vehicle * ECF843 vehicle TID * ECF843 0.15 mg/mL twice daily (BID) or vehicle * ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle. The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.
Interventions
DRUGECF843
Topical ocular eye drop
OTHERECF843 vehicle
Topical ocular eye drop
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any assessment * Adult male or female subjects 18 years of age or older * At least 6 months history of dry eye disease in both eyes * Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis * Composite corneal fluorescein staining score \>= 4 (modified National Eye Institute (NEI) scale) in at least one eye * Schirmer score \>= 1 and =\< 10 mm after 5 minutes in at least one eye * Patients with Sjögren's Syndrome must have dry eye
Exclusion criteria
* Ocular infection in either eye within 30 days prior to Screening * Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit * Use of contact lenses in either eye within 14 days of Screening * Uncontrolled ocular rosacea * Clinically significant conjunctivochalasis in either eye * Other Corneal conditions affecting the corneal structure * Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson Syndrome, sarcoidosis * Currently active, or history of ocular allergies during the time of year the patient will be participating in the study * Patients with current punctal plugs or punctal cauterization or occlusion * Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening. * Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening * Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening * History of malignancy of any organ system within the past five years * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | Up to 28 days (Baseline (BL) to end of randomized treatment) | The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement. |
| Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | Up to 28 days (Baseline (BL) to end of randomized treatment) | The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Change From Baseline in Central Corneal Fluorescein Staining | Up to 28 days (Baseline (BL) to end of randomized treatment) | The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. |
| Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | Up to 28 days (Baseline (BL) to end of randomized treatment) | The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. |
| Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Up to 28 days (Baseline (BL) to end of randomized treatment) | The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe. Treatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term. |
Countries
United States
Participant flow
Recruitment details
This study was conducted in 53 sites in the USA.
Pre-assignment details
Approximately 800 subjects were planned to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period. A total of 970 subjects were screened, of which 558 subjects received randomized treatment.
Participants by arm
| Arm | Count |
|---|---|
| ECF843 0.45 mg/mL TID (Part 1) ECF843 0.45 mg/mL ter in die/three times a day (TID) (Part 1) | 111 |
| ECF843 0.15 mg/mL TID (Part 1) ECF843 0.15 mg/mL ter in die/three times a day (TID) (Part 1) | 112 |
| ECF843 Vehicle TID (Part 1) ECF843 vehicle ter in die/three times a day (TID) (Part 1) | 112 |
| ECF843 0.15 mg/mL BID (Part 1) ECF843 0.15 mg/mL bis in diem/twice a day (BID) (Part 1) | 109 |
| ECF843 Vehicle BID (Part 1) ECF843 vehicle bis in diem/twice a day (BID) (Part 1) | 114 |
| Total | 558 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Unsatisfactory Therapeutic effect | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | ECF843 0.45 mg/mL TID (Part 1) | ECF843 0.15 mg/mL TID (Part 1) | ECF843 Vehicle TID (Part 1) | ECF843 0.15 mg/mL BID (Part 1) | ECF843 Vehicle BID (Part 1) |
|---|---|---|---|---|---|---|
| Age, Continuous | 62.0 Years STANDARD_DEVIATION 13.33 | 61.7 Years STANDARD_DEVIATION 13.68 | 60.6 Years STANDARD_DEVIATION 13.64 | 62.1 Years STANDARD_DEVIATION 12.89 | 62.9 Years STANDARD_DEVIATION 13.51 | 62.7 Years STANDARD_DEVIATION 13.04 |
| Age, Customized < 65 years | 279 Participants | 56 Participants | 60 Participants | 55 Participants | 49 Participants | 59 Participants |
| Age, Customized >= 65 years | 279 Participants | 55 Participants | 52 Participants | 57 Participants | 60 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 83 Participants | 15 Participants | 20 Participants | 17 Participants | 12 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 475 Participants | 96 Participants | 92 Participants | 95 Participants | 97 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 5 Participants | 6 Participants | 3 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants | 16 Participants | 17 Participants | 24 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 451 Participants | 89 Participants | 88 Participants | 85 Participants | 90 Participants | 99 Participants |
| Sex: Female, Male Female | 423 Participants | 83 Participants | 89 Participants | 86 Participants | 82 Participants | 83 Participants |
| Sex: Female, Male Male | 135 Participants | 28 Participants | 23 Participants | 26 Participants | 27 Participants | 31 Participants |
| Sjogren's Syndrome status No | 539 Participants | 107 Participants | 108 Participants | 108 Participants | 107 Participants | 109 Participants |
| Sjogren's Syndrome status Yes | 19 Participants | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 112 | 0 / 112 | 0 / 109 | 0 / 114 |
| other Total, other adverse events | 9 / 111 | 15 / 112 | 5 / 112 | 5 / 109 | 12 / 114 |
| serious Total, serious adverse events | 0 / 111 | 0 / 112 | 1 / 112 | 0 / 109 | 1 / 114 |
Outcome results
Primary
Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score
The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.
Time frame: Up to 28 days (Baseline (BL) to end of randomized treatment)
Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | -1.1 Score on scale | Standard Error 0.3 |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | -1.0 Score on scale | Standard Error 0.3 |
| ECF843 Vehicle TID (Part 1) | Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | -0.9 Score on scale | Standard Error 0.3 |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | -1.0 Score on scale | Standard Error 0.31 |
| ECF843 Vehicle BID (Part 1) | Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score | -1.1 Score on scale | Standard Error 0.3 |
p-value: 0.60595% CI: [-0.8, 0.4]Mixed Models Analysis
p-value: 0.64695% CI: [-0.7, 0.5]Mixed Models Analysis
p-value: 0.84795% CI: [-0.5, 0.7]Mixed Models Analysis
Primary
Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score
The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.
Time frame: Up to 28 days (Baseline (BL) to end of randomized treatment)
Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | -6.0 Score on scale | Standard Error 1.86 |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | -8.1 Score on scale | Standard Error 1.85 |
| ECF843 Vehicle TID (Part 1) | Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | -4.9 Score on scale | Standard Error 1.85 |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | -1.8 Score on scale | Standard Error 1.91 |
| ECF843 Vehicle BID (Part 1) | Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score | -6.1 Score on scale | Standard Error 1.84 |
p-value: 0.58595% CI: [-5, 2.8]Mixed Models Analysis
p-value: 0.10795% CI: [-7.01, 0.7]Mixed Models Analysis
p-value: 0.03395% CI: [0.3, 8.3]Mixed Models Analysis
Secondary
Part 1: Change From Baseline in Central Corneal Fluorescein Staining
The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.
Time frame: Up to 28 days (Baseline (BL) to end of randomized treatment)
Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Change From Baseline in Central Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.8 |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Change From Baseline in Central Corneal Fluorescein Staining | -0.3 Score on scale | Standard Deviation 0.78 |
| ECF843 Vehicle TID (Part 1) | Part 1: Change From Baseline in Central Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.83 |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Change From Baseline in Central Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.65 |
| ECF843 Vehicle BID (Part 1) | Part 1: Change From Baseline in Central Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.74 |
95% CI: [-0.2, 0.2]
95% CI: [-0.3, 0.1]
95% CI: [-0.2, 0.2]
Secondary
Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining
The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.
Time frame: Up to 28 days (Baseline (BL) to end of randomized treatment)
Population: Full Analysis Set 1 including subjects with a value at both Baseline and post-baseline visit. Baseline is defined as the last available value collected prior to or on the first administration of randomized study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.75 |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | -0.3 Score on scale | Standard Deviation 0.85 |
| ECF843 Vehicle TID (Part 1) | Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.89 |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | -0.2 Score on scale | Standard Deviation 0.98 |
| ECF843 Vehicle BID (Part 1) | Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining | -0.6 Score on scale | Standard Deviation 1.06 |
95% CI: [-0.2, 0.2]
95% CI: [-0.3, 0.1]
95% CI: [0.1, 0.6]
Secondary
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs)
The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe. Treatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.
Time frame: Up to 28 days (Baseline (BL) to end of randomized treatment)
Population: Safety Set 1
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Moderate | 0 Participants |
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Moderate | 1 Participants |
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Mild | 4 Participants |
| ECF843 0.45 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Mild | 5 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Moderate | 0 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Mild | 10 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Mild | 5 Participants |
| ECF843 0.15 mg/mL TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Moderate | 1 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Moderate | 1 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Mild | 4 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Moderate | 1 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Mild | 0 Participants |
| ECF843 Vehicle TID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Moderate | 2 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Mild | 1 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Mild | 2 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 0.15 mg/mL BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Moderate | 0 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Mild | 7 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Moderate | 0 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Ocular treatment emergent adverse events | Severe | 0 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Mild | 3 Participants |
| ECF843 Vehicle BID (Part 1) | Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) | Non-ocular treatment emergent adverse events | Moderate | 1 Participants |