Dry Eye
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 dry eye disease
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
No
Inclusion criteria
* Had a known history of dry eye disease * Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye
Exclusion criteria
* History of intraocular inflammation in either eye * Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study * Uncontrolled glaucoma or is on medications to treat glaucoma * History of IOP spikes in either eye * Active epiphora
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining | Day 15 | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining) |
| Total Conjunctival Lissamine Green Staining | Day 15 | National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-DP OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | 22 |
| Placebo Vehicle PV (placebo drug delivery vehicle) | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | OTX-DP | Placebo Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years | 62.5 years | 62.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Blue | 5 Participants | 10 Participants | 15 Participants |
| Iris Color Brown | 8 Participants | 7 Participants | 15 Participants |
| Iris Color Green | 2 Participants | 1 Participants | 3 Participants |
| Iris Color Hazel | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 30 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 15 / 22 | 11 / 21 |
| serious Total, serious adverse events | 1 / 22 | 0 / 21 |
Outcome results
Primary
Total Conjunctival Lissamine Green Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Total Conjunctival Lissamine Green Staining | 4.36 units on a scale | Standard Deviation 2.517 |
| Placebo Vehicle | Total Conjunctival Lissamine Green Staining | 5.67 units on a scale | Standard Deviation 4.199 |
Primary
Total Conjunctival Lissamine Green Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Total Conjunctival Lissamine Green Staining | 6.41 units on a scale | Standard Deviation 2.13 |
| Placebo Vehicle | Total Conjunctival Lissamine Green Staining | 7.81 units on a scale | Standard Deviation 3.642 |
Primary
Total Corneal Fluorescein Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Time frame: Day 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Total Corneal Fluorescein Staining | 4.09 units on a scale | Standard Deviation 2.671 |
| Placebo Vehicle | Total Corneal Fluorescein Staining | 5.05 units on a scale | Standard Deviation 3.041 |
Primary
Total Corneal Fluorescein Staining
National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-DP | Total Corneal Fluorescein Staining | 4.64 units on a scale | Standard Deviation 2.361 |
| Placebo Vehicle | Total Corneal Fluorescein Staining | 6.38 units on a scale | Standard Deviation 3.278 |