NCT06174935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 28, 2023

Last Update Submit

December 8, 2023

Conditions

Vitreous Floaters

Outcome Measures

Primary Outcomes (1)

  • Symptom improvement assessed by questionnaire

    NEI VFQ-25 = National Eye Institute Visual Function Questionnaire

    Up to 2 months

Study Arms (1)

Atropine 0.01%

EXPERIMENTAL

Patients will apply 1 drop daily of atropine 0.01%

Drug: 0.01% atropine ophthalmic drop

Interventions

0.01% atropine ophthalmic dropDRUG

0.01% atropine ophthalmic drop will be applied daily to the affected eye

Atropine 0.01%

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Group of Washington

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

vitreous floaters

Central Study Contacts

Jeanette Du, MD

CONTACT

844-749-3627JDu@rgw.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 18, 2023

Study Start

January 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)