A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

iDrop

Status and phase: Completed; Phase 2; Phase 1

Conditions: Inflammation Eye

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03687931

C-01

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 two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion criteria

• Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
• Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
• Patients who are known steroid responders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm 1

Experimental group

Description:

Dexamethasone suspension dose level 1

Treatment:

Drug: Dexamethasone

Arm 2

Experimental group

Description:

Dexamethasone suspension dose level 2

Treatment:

Drug: Dexamethasone