Ocular Inflammation and Pain
Conditions
Brief summary
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Interventions
DRUGOTX-DP (Dexamethasone punctum plug)
Sustained and tapered release of dexamethasone from hydrogel punctum plug
DRUGPlacebo Vehicle Punctum Plug
Hydrogel punctum plug without dexamethasone
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule * Is greater than or equal to 21 years of age * Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
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 at Screening * Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of Cells in Anterior Chamber of Study Eye | Day 8 |
| Absence of Pain in the Study Eye | Day 8 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Duration of each individual subject's participation in the study, up to 60 days | Measure of adverse events over the duration of each subject's participation in the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Punctum Plug Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug | 30 |
| Placebo Vehicle Punctum Plug Placebo punctum plug insertion
Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Dexamethasone Punctum Plug | Placebo Vehicle Punctum Plug | Total |
|---|---|---|---|
| Age, Customized Age between 21 - 65 | 14 Participants | 9 Participants | 23 Participants |
| Age, Customized Age greater than or equal to 65 | 16 Participants | 21 Participants | 37 Participants |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 29 | 10 / 30 |
| serious Total, serious adverse events | 0 / 29 | 1 / 30 |
Outcome results
Primary
Absence of Cells in Anterior Chamber of Study Eye
Time frame: Day 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Punctum Plug | Absence of Cells in Anterior Chamber of Study Eye | 6 Participants |
| Placebo Vehicle Punctum Plug | Absence of Cells in Anterior Chamber of Study Eye | 3 Participants |
Primary
Absence of Pain in the Study Eye
Time frame: Day 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Punctum Plug | Absence of Pain in the Study Eye | 23 Participants |
| Placebo Vehicle Punctum Plug | Absence of Pain in the Study Eye | 9 Participants |
Other Pre-specified
Adverse Events
Measure of adverse events over the duration of each subject's participation in the study.
Time frame: Duration of each individual subject's participation in the study, up to 60 days
Population: Ocular adverse events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone Punctum Plug | Adverse Events | 4 Participants |
| Placebo Vehicle Punctum Plug | Adverse Events | 7 Participants |