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

A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03687931

Enrollment

Registered

2018-09-27

Start date

2018-08-26

Completion date

2019-02-28

Last updated

2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Eye

Brief summary

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.

Interventions

DRUGDexamethasone

Drop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Anterior Chamber Cell	30 days	Number of cells in the anterior chamber

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026