Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Conditions
Brief summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
Interventions
DRUGDexamethasone
OTHERPlacebo Vehicle
Sponsors
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 cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens * Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
Exclusion criteria
* Any intraocular inflammation in the study eye present during the screening slit lamp examination * Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening * Any intraocular inflammation in the study eye present during the screening slit lamp examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Anterior Chamber Inflammation | Day 14 | Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14 |
| Absence of Ocular Pain | Day 8 | Absence of pain (i.e., score of '0') in the study eye at Day 8 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-DP OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | 216 |
| Placebo Vehicle PV (placebo drug delivery vehicle) | 222 |
| Total | 438 |
Baseline characteristics
| Characteristic | Total | Placebo Vehicle | OTX-DP |
|---|---|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 8.75 | 68.6 years STANDARD_DEVIATION 8.37 | 67.3 years STANDARD_DEVIATION 9.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 74 Participants | 37 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 364 Participants | 185 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Iris Color Black | 2 Participants | 2 Participants | 0 Participants |
| Iris Color Blue | 125 Participants | 64 Participants | 61 Participants |
| Iris Color Brown | 207 Participants | 101 Participants | 106 Participants |
| Iris Color Gray | 2 Participants | 0 Participants | 2 Participants |
| Iris Color Green | 33 Participants | 18 Participants | 15 Participants |
| Iris Color Hazel | 69 Participants | 37 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 25 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 363 Participants | 189 Participants | 174 Participants |
| Sex: Female, Male Female | 250 Participants | 130 Participants | 120 Participants |
| Sex: Female, Male Male | 188 Participants | 92 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 216 | 0 / 221 |
| other Total, other adverse events | 63 / 216 | 86 / 221 |
| serious Total, serious adverse events | 3 / 216 | 2 / 221 |
Outcome results
Primary
Absence of Anterior Chamber Inflammation
Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
Time frame: Day 14
Population: ITT LOCF (last observation carried forward)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OTX-DP | Absence of Anterior Chamber Inflammation | 52.3 percentage of total participants |
| Placebo Vehicle | Absence of Anterior Chamber Inflammation | 31.1 percentage of total participants |
Primary
Absence of Ocular Pain
Absence of pain (i.e., score of '0') in the study eye at Day 8
Time frame: Day 8
Population: ITT LOCF (last observation carried forward)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OTX-DP | Absence of Ocular Pain | 79.6 percentage of total participants |
| Placebo Vehicle | Absence of Ocular Pain | 61.3 percentage of total participants |