Cataract
Conditions
Keywords
Dextenza, dexamethasone ophthalmic insert
Brief summary
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Detailed description
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
Interventions
DRUGDextenza Ophthalmic Insert
0.4mg insert for intracanalicular use
DRUGPrednisolone acetate ophthalmic suspension USP 1%
1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is \>5 years of age) * Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens
Exclusion criteria
* Any intraocular inflammation in the study eye present during the screening slit lamp examination * Has ocular hypertension (defined as IOP of \>21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases * Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to approximately 42 days after surgery | Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs) |
| Subject FLACC Pain Assessment | From screening through day 42 | Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain). |
| IOP | From screening, then day 2 through 42 | IOP measured in units of mmHg. |
Countries
United States
Outcome results
None listed