Chronic Allergic Conjunctivitis
Conditions
Brief summary
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
Interventions
OTHERPlacebo Vehicle
DRUGDexamethasone
Sponsors
ORA, Inc.
Ocular Therapeutix, Inc.
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
* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation
Exclusion criteria
* History of refractive surgery (including LASIK procedures) within the past 2 years * History of retinal detachment, diabetic retinopathy, or active retinal disease * Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * Use any of the disallowed medications during the period indicated * History of IOP increase as a result of steroid treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 3 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching |
| Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 | 5 minutes | Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-DP OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | 44 |
| Placebo Vehicle PV (placebo drug delivery vehicle) | 42 |
| Total | 86 |
Baseline characteristics
| Characteristic | OTX-DP | Placebo Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 39.1 years | 42.2 years | 40 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 10 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 32 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Black | 1 Participants | 0 Participants | 1 Participants |
| Iris Color Blue | 6 Participants | 15 Participants | 21 Participants |
| Iris Color Brown | 24 Participants | 19 Participants | 43 Participants |
| Iris Color Green | 8 Participants | 5 Participants | 13 Participants |
| Iris Color Hazel | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 40 Participants | 75 Participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 40 |
| other Total, other adverse events | 6 / 41 | 11 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
Primary
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 | 2.07 units on a scale | Standard Deviation 1.1 |
| Placebo Vehicle | Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 | 2.41 units on a scale | Standard Deviation 1.039 |
Primary
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time frame: 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 2.04 units on a scale | Standard Deviation 1.088 |
| Placebo Vehicle | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 2.31 units on a scale | Standard Deviation 1.115 |
Primary
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Time frame: 7 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 2.02 units on a scale | Standard Deviation 1.131 |
| Placebo Vehicle | Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 | 2.37 units on a scale | Standard Deviation 1.129 |