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
DRUGDexamethasone
OTHERPlacebo Vehicle
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
Yes
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 ocular surgical intervention within the past 3 months * Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * Use any of the following disallowed medications during the period indicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | 14 days post insertion | Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness | 14 days post insertion | Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-DP Treatment OTX-DP (sustained release dexamethasone, 0.4 mg)
OTX-DP treatment | 35 |
| Placebo Plug Delivery Vehicle Placebo Plug with no drug
Placebo Plug with no drug | 33 |
| Total | 68 |
Baseline characteristics
| Characteristic | OTX-DP Treatment | Placebo Plug Delivery Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 30 Participants | 64 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 31 | 2 / 33 |
| serious Total, serious adverse events | 1 / 31 | 0 / 33 |
Outcome results
Primary
Ocular Itching
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching)
Time frame: 14 days post insertion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OTX-DP Treatment | Ocular Itching | 3 min (14 days post-insertion) | 1.80 units on a scale (0 -4) | Standard Deviation 1.068 |
| OTX-DP Treatment | Ocular Itching | 5 min. (14 days post-insertion) | 1.72 units on a scale (0 -4) | Standard Deviation 0.998 |
| OTX-DP Treatment | Ocular Itching | 7 min. (14 days post-insertion) | 1.65 units on a scale (0 -4) | Standard Deviation 0.989 |
| Placebo Plug Delivery Vehicle | Ocular Itching | 3 min (14 days post-insertion) | 2.58 units on a scale (0 -4) | Standard Deviation 0.823 |
| Placebo Plug Delivery Vehicle | Ocular Itching | 5 min. (14 days post-insertion) | 2.70 units on a scale (0 -4) | Standard Deviation 0.865 |
| Placebo Plug Delivery Vehicle | Ocular Itching | 7 min. (14 days post-insertion) | 2.53 units on a scale (0 -4) | Standard Deviation 0.88 |
Secondary
Conjunctival Redness
Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness)
Time frame: 14 days post insertion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OTX-DP Treatment | Conjunctival Redness | 15 min. (14 days post-insertion) | 1.53 units on a scale (0 - 4) | Standard Deviation 0.753 |
| OTX-DP Treatment | Conjunctival Redness | 7 min. (14 days post-insertion) | 1.60 units on a scale (0 - 4) | Standard Deviation 0.753 |
| OTX-DP Treatment | Conjunctival Redness | 20 min. (14 days post-insertion) | 1.54 units on a scale (0 - 4) | Standard Deviation 0.739 |
| Placebo Plug Delivery Vehicle | Conjunctival Redness | 7 min. (14 days post-insertion) | 2.11 units on a scale (0 - 4) | Standard Deviation 0.727 |
| Placebo Plug Delivery Vehicle | Conjunctival Redness | 15 min. (14 days post-insertion) | 2.23 units on a scale (0 - 4) | Standard Deviation 0.708 |
| Placebo Plug Delivery Vehicle | Conjunctival Redness | 20 min. (14 days post-insertion) | 2.21 units on a scale (0 - 4) | Standard Deviation 0.696 |