Allergic Conjunctivitis
Conditions
Brief summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Interventions
DRUGEM-100
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
DRUGZaditor®
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
DRUGVehicle
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Sponsors
ORA, Inc.
Bausch & Lomb Incorporated
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 old * have a positive history of allergic conjunctivitis and positive skin test reaction to allergens * be willing to avoid disallowed medications for the appropriate washout period and throughout the trial * be willing to avoid contact lens use * be willing to have a pregnancy test * must be able to read an eye chart from 10 feet away
Exclusion criteria
* must not have any allergies to the study medications * must not have any ocular or non ocular condition that investigator feels will interfere with study parameters * must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 | Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness | 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 | The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed). |
Countries
United States
Participant flow
Recruitment details
There were 65 participants enrolled (130 eyes). 38 participants received EM-100 in one eye and Zaditor in the other eye. 13 participants received EM-100 in one eye and vehicle in the other eye. 14 participants received Zaditor in one eye and vehicle in the other eye. Thus, of 65 participants, 51 received EM-100 in one of their eyes, 52 received Zaditor in one of their eyes, and 27 received vehicle in one of their eyes. Each participant received 2 of the 3 study treatments, one in each eye.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye). Demographic data were not collected by treatment or by eye. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 12.16 |
| Iris color Black | 1 Participants |
| Iris color Blue | 8 Participants |
| Iris color Brown | 46 Participants |
| Iris color Green | 4 Participants |
| Iris color Hazel | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Ocular Itching
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
Time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Population: The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EM-100 | Ocular Itching | 5 minutes post CAC | 1.09 score on a scale | Standard Deviation 1.047 |
| EM-100 | Ocular Itching | 3 minutes post CAC | 0.81 score on a scale | Standard Deviation 0.787 |
| EM-100 | Ocular Itching | 7 minutes post CAC | 1.17 score on a scale | Standard Deviation 1.103 |
| Zaditor® | Ocular Itching | 5 minutes post CAC | 1.04 score on a scale | Standard Deviation 0.989 |
| Zaditor® | Ocular Itching | 3 minutes post CAC | 0.79 score on a scale | Standard Deviation 0.75 |
| Zaditor® | Ocular Itching | 7 minutes post CAC | 1.04 score on a scale | Standard Deviation 1.047 |
| Vehicle | Ocular Itching | 3 minutes post CAC | 1.98 score on a scale | Standard Deviation 0.935 |
| Vehicle | Ocular Itching | 7 minutes post CAC | 2.22 score on a scale | Standard Deviation 1.032 |
| Vehicle | Ocular Itching | 5 minutes post CAC | 2.17 score on a scale | Standard Deviation 1 |
Secondary
Conjunctival Redness
The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).
Time frame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Population: The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EM-100 | Conjunctival Redness | 15 minutes post-CAC | 2.25 score on a scale | Standard Deviation 0.783 |
| EM-100 | Conjunctival Redness | 7 minutes post-CAC | 2.13 score on a scale | Standard Deviation 0.824 |
| EM-100 | Conjunctival Redness | 20 minutes post-CAC | 2.16 score on a scale | Standard Deviation 0.857 |
| Zaditor® | Conjunctival Redness | 15 minutes post-CAC | 2.29 score on a scale | Standard Deviation 0.737 |
| Zaditor® | Conjunctival Redness | 7 minutes post-CAC | 2.14 score on a scale | Standard Deviation 0.743 |
| Zaditor® | Conjunctival Redness | 20 minutes post-CAC | 2.24 score on a scale | Standard Deviation 0.704 |
| Vehicle | Conjunctival Redness | 7 minutes post-CAC | 2.72 score on a scale | Standard Deviation 0.725 |
| Vehicle | Conjunctival Redness | 20 minutes post-CAC | 2.46 score on a scale | Standard Deviation 0.784 |
| Vehicle | Conjunctival Redness | 15 minutes post-CAC | 2.61 score on a scale | Standard Deviation 0.847 |