A Clinical Study to Assess the Efficacy and Safety of Dex... | NCT03687931

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

NCT03687931

Sponsor

iDrop, Inc.

Status

Completed

Last Update Posted

May 24, 2019Actual

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Inflammation Eye

Interventions

Dexamethasone

Countries

United States

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

May 2019

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

Aug 26, 2018Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Sep 26, 2018

First Submission Date that Met QC Criteria

Sep 26, 2018

First Posted Date

Sep 27, 2018Actual

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

May 23, 2019

Last Update Posted Date

May 24, 2019Actual

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 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.

Detailed Description

Not provided

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 1Phase 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	Description	Intervention Names
Arm 1	Experimental	Dexamethasone suspension dose level 1	Drug: Dexamethasone
Arm 2	Experimental	Dexamethasone suspension dose level 2	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Drop	Arm 1 Arm 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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
William White	iDrop, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Eye Center		Chandler	Arizona	85224	United States

Condition Browse Module

MeSH Terms

ID	Term
D009877	Endophthalmitis

Ancestor Terms

ID	Term
D015817	Eye Infections
D007239	Infections
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided