A Clinical Study to Assess the Efficacy and Safety of SED... | NCT04711213

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

NCT04711213

Sponsor

iDrop, Inc.

Status

Completed

Last Update Posted

Jan 15, 2021Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Cataract in Inflammatory Ocular Disorders

Interventions

Dexamethasone Dose 1
Dexamethasone Dose 2
Placebo Dose 1
Placebo Dose 2

Countries

El Salvador

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2020Actual

Primary Completion Date

Oct 31, 2020Actual

Completion Date

Nov 15, 2020Actual

First Submitted Date

Sep 23, 2020

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Dexamethasone Dose 1	Active Comparator	Drug: Dexamethasone Dose 1
Dexamethasone Dose 2	Active Comparator	Drug: Dexamethasone Dose 2
Placebo Dose 1	Placebo Comparator	Drug: Placebo Dose 1
Placebo Dose 2	Placebo Comparator	Drug: Placebo Dose 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone Dose 1	Drug	Dexamethasone ophthalmic suspension dose 1	Dexamethasone Dose 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular inflammation	Measuring Anterior Cell Count	Day 8

Secondary Outcomes

Measure	Description	Time Frame
Ocular Pain	Measuring patient ocular pain using an 11-point visual scale	Day 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing traditional cataract surgery.

Exclusion Criteria:

Patients with unusual ocular conditions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel Casada, MD	President - Centre De. Oftalmolgia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre De. Oftalmologia		San Salvador			El Salvador

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided