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Low Dose Atropine for Symptomatic Vitreous Floaters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06174935
Recruitment Status : Not yet recruiting
First Posted : December 18, 2023
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
Jeanette Du, Prism Vision Group

Tracking Information
First Submitted Date  ICMJE November 28, 2023
First Posted Date  ICMJE December 18, 2023
Last Update Posted Date December 18, 2023
Estimated Study Start Date  ICMJE January 1, 2024
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2023)		 Symptom improvement assessed by questionnaire [ Time Frame: Up to 2 months ]
NEI VFQ-25 = National Eye Institute Visual Function Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Atropine for Symptomatic Vitreous Floaters
Official Title  ICMJE Low Dose Atropine For Symptomatic Vitreous Floaters
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitreous Floaters
Intervention  ICMJE Drug: 0.01% atropine ophthalmic drop
0.01% atropine ophthalmic drop will be applied daily to the affected eye
Study Arms  ICMJE Experimental: Atropine 0.01%
Patients will apply 1 drop daily of atropine 0.01%
Intervention: Drug: 0.01% atropine ophthalmic drop
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2023)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeanette Du, MD 844-749-3627 JDu@rgw.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06174935
Other Study ID Numbers  ICMJE 1362664
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jeanette Du, Prism Vision Group
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jeanette Du
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Prism Vision Group
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP