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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566717
Other study ID # ASSESS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date October 31, 2022

Study information

Verified date September 2022
Source Medical Center Ophthalmology Associates
Contact Lolita Kirschbaum
Phone 2106972006
Email lkirschbaum@mcoaeyecare.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Medical Center Ophthalmology Associates San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Medical Center Ophthalmology Associates Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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