An Investigator-Initiated Study to Assess the Association... | NCT05566717

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Oct 31, 2022Estimated

First Submitted Date

Aug 2, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 4, 2022Actual

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

Sep 30, 2022

Last Update Posted Date

Oct 4, 2022Actual

Name	Class
Oyster Point Pharma, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

Detailed Description

This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Endpoint	• To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes	3months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have Type 1 or Type 2 diabetes with DRSS of 3 or higher
Be willing and able to sign the informed consent form (ICF)
Be at least 18 years of age
Be literate and able to complete questionnaires independently
Have provided verbal and written informed consent

Exclusion Criteria:

Have a history of vitrectomy
Have a history of cornea, eyelid, glaucoma, or retina surgery
Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia
Have a history of ocular herpes simplex virus infection
Have a history of herpes zoster ophthalmicus
Have a history of ocular chemical trauma
Have a history of underlying corneal dystrophies
Have had cataract surgery less than 3 months prior
Have a history of pan-retinal photocoagulation (PRP)
Have current Stage 2 or 3 neurotrophic keratopathy
Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This is a single-center, controlled study to assess the association of diabetic retinopathy severity with reduction in corneal sensitivity in approximately 50 Type 1 and Type 2 diabetes subjects (100 eyes) at least 18 years of age and meeting all other study eligibility criteria.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Lolita Kirschbaum	Contact	2106972006		lkirschbaum@mcoaeyecare.com

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center Ophthalmology Associates	Recruiting	San Antonio	Texas	78240	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared however demographics and baseline characteristics will be summarized.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases