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

Phase 2

Completed

• Conditions: Cataract in Inflammatory Ocular Disorders
• Interventions: Drug: Dexamethasone Dose 1; Drug: Dexamethasone Dose 2; Drug: Placebo Dose 1; Drug: Placebo Dose 2

• Registration Number: NCT04711213
• Lead Sponsor: iDrop, Inc.

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.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-14
• Study First Submitted: 2020-09-23
• Primary Completion: 2020-10-31
• Study Completion: 2020-11-15
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing traditional cataract surgery.

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Exclusion Criteria

• Patients with unusual ocular conditions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Dose 1	Dexamethasone Dose 1	-
Dexamethasone Dose 2	Dexamethasone Dose 2	-
Placebo Dose 1	Placebo Dose 1	-
Placebo Dose 2	Placebo Dose 2	-

Primary Outcome Measures

Name	Time	Method
Ocular inflammation	Day 8	Measuring Anterior Cell Count

Secondary Outcome Measures

Name	Time	Method
Ocular Pain	Day 8	Measuring patient ocular pain using an 11-point visual scale

Trial Locations

Locations (1)

Centre De. Oftalmologia; 🇸🇻 San Salvador, El Salvador