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
PROCEDUREPlacebo 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 a 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 |
|---|---|---|
| Number of Participants With an 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 |
| Number of Participants With an 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 (Dexamethasone Punctum Plug) Resorbable hydrogel drug delivery vehicle containing dexamethasone
Dexamethasone | 161 |
| PVPP (Placebo Punctum Plug) Resorbable hydrogel drug delivery vehicle containing no drug
Punctum Plug | 80 |
| Total | 241 |
Baseline characteristics
| Characteristic | OTX-DP (Dexamethasone Punctum Plug) | PVPP (Placebo Punctum Plug) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 112 Participants | 58 Participants | 170 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 22 Participants | 71 Participants |
| Sex: Female, Male Female | 98 Participants | 39 Participants | 137 Participants |
| Sex: Female, Male Male | 63 Participants | 41 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 160 | 0 / 80 |
| serious Total, serious adverse events | 0 / 160 | 1 / 80 |
Outcome results
Primary
Number of Participants With an 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OTX-DP | Number of Participants With an Absence of Anterior Chamber Inflammation | 63 participants |
| Placebo Vehicle | Number of Participants With an Absence of Anterior Chamber Inflammation | 25 participants |
Primary
Number of Participants With an Absence of Ocular Pain
Absence of pain (i.e., score of '0') in the study eye at Day 8
Time frame: Day 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OTX-DP | Number of Participants With an Absence of Ocular Pain | 124 participants |
| Placebo Vehicle | Number of Participants With an Absence of Ocular Pain | 47 participants |