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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-26

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04711213

Cataract in Inflammatory Ocular Disorders

COMPLETED PHASE2

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

NCT04184999

Dry Eye Syndromes

COMPLETED PHASE4

A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery

NCT04205916

Patient Preference

RECRUITING PHASE4

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

NCT05626478

Corneal Edema Corneal Defect Anterior Chamber Inflammation +4 more

COMPLETED PHASE4

OCS-01 in Treating Inflammation and Pain in Post-cataract Patients

NCT04130802

Inflammation Corneal Pain, Postoperative

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Dexamethasone suspension dose level 1

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Drop

Arm 2

Dexamethasone suspension dose level 2

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Drop

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Drop

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No