A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

iDrop

Status and phase: Completed; Phase 2

Conditions: Cataract in Inflammatory Ocular Disorders

Treatments: Drug: Placebo Dose 2; Drug: Placebo Dose 1; Drug: Dexamethasone Dose 2; Drug: Dexamethasone Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04711213

C-02

Details and patient eligibility

About

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.

Full description

"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing traditional cataract surgery.

Exclusion criteria

• Patients with unusual ocular conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

Dexamethasone Dose 1

Active Comparator group

Treatment:

Drug: Dexamethasone Dose 1

Dexamethasone Dose 2

Active Comparator group

Treatment:

Drug: Dexamethasone Dose 2

Placebo Dose 1

Placebo Comparator group

Treatment:

Drug: Placebo Dose 1

Placebo Dose 2

Placebo Comparator group

Treatment:

Drug: Placebo Dose 2