Cataract in Inflammatory Ocular Disorders
Conditions
Brief summary
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
Detailed description
Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.
Interventions
DRUGDexamethasone Dose 1
Dexamethasone ophthalmic suspension dose 1
DRUGDexamethasone Dose 2
Dexamethasone ophthalmic suspension dose 2
DRUGPlacebo Dose 1
Placebo suspension dose 1
DRUGPlacebo Dose 2
Placebo suspension dose 2
Sponsors
iDrop, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single Masked randomized study
Intervention model description
Randomized to 2 active dosing groups and 2 corresponding dosing groups
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing traditional cataract surgery.
Exclusion criteria
* Patients with unusual ocular conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular inflammation | Day 8 | Measuring Anterior Cell Count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Pain | Day 8 | Measuring patient ocular pain using an 11-point visual scale |
Countries
El Salvador
Outcome results
None listed