Low Dose Atropine for Symptomatic Vitreous Floaters | NCT06174935

Studies
Low Dose Atropine for Symptomatic Vitreous Floaters

NCT06174935

Sponsor

Jeanette Du

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Vitreous Floaters

Interventions

0.01% atropine ophthalmic drop

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Nov 28, 2023

First Submission Date that Met QC Criteria

Dec 8, 2023

First Posted Date

Dec 18, 2023Actual

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

Dec 8, 2023

Last Update Posted Date

Dec 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The objective of this study is to identify a potential pharmacologic option by assessing whether 0.01% atropine may be effective for treating bothersome floaters as measured by scores on a modified NEI VFQ-25.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atropine 0.01%	Experimental	Patients will apply 1 drop daily of atropine 0.01%	Drug: 0.01% atropine ophthalmic drop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.01% atropine ophthalmic drop	Drug	0.01% atropine ophthalmic drop will be applied daily to the affected eye	Atropine 0.01%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom improvement assessed by questionnaire	NEI VFQ-25 = National Eye Institute Visual Function Questionnaire	Up to 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients within Prism Vision Group with ICD diagnosis of acute posterior vitreous detachment and none of the ocular comorbidities listed as exclusion criteria will be screened as potential study participants.

Exclusion Criteria:

Patients with vitreous hemorrhage, other significant media opacity or vitreoretinal pathology, or history of pars plana vitrectomy will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeanette Du, MD	Contact	844-749-3627		JDu@rgw.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Group of Washington		Reston	Virginia	20190	United States

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

Condition Browse Module

MeSH Terms

ID	Term
C000726608	vitreous floaters

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided