Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-20-262 - SBIR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement

PA-20-261 - STTR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement

PA-20-260 - SBIR Omnibus/Parent Clinical Trial Not Allowed Funding Opportunity Announcement

PA-20-265 - STTR Omnibus/Parent Clinical Trial Not Allowed Funding Opportunity Announcement

Issued by

National Eye Institute (NEI)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to inform potential applicants of the special interest of the NEI in research to identify new biomarkers and develop effective methods that can be used for the early diagnosis of dry eye disease (DED) and its subtypes, prognosis of disease progression, and monitoring of treatment response.

Background

As defined by the Tear Film and Ocular Surface Society (TFOS), “Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.” (TFOS dry eye workshop, 2017). Prevalence estimates for DED range anywhere from 5% to 30% in individuals over the age of 50, with a higher prevalence in females. Despite the common occurrence of DED, diagnosis is challenging for diverse reasons, including the complicated etiologic mechanisms underlying the disease and poor correlation between clinical signs and symptoms. There is no well accepted gold standard to diagnose DED. Current diagnosis and clinical evaluation are often subjective and typically based on patient-reported symptoms. Since DED testing and/or treatments are not performed until a patient is symptomatic, current treatments for DED usually focus on resolving the symptoms, rather than on targeting the underlying cause of DED. There is a significant need for objective, validated, reliable, and reproducible diagnostic methods for DED.

Research Objectives

This NOSI seeks to support investigation into effective methods to diagnose dry eye disease not based on whether symptoms are present. This includes the diagnosing and monitoring of DED in asymptomatic patients for developing clinical signs. A critical outcome is understanding applicability of the critical features of DED to aid in accurate diagnosis and effective treatment of DED.

This NOSI encourages, but is not limited to, research applications in the following areas:

• Identification and validation of biomarkers or profiles/signatures that are associated with the development of dry eye disease and that can be used for early diagnosis, prognosis, and monitoring of treatment response.
• Identification of the key factors that distinguish the two broad subtypes of dry eye disease- evaporative dry eye and aqueous deficient dry eye.
• Investigation of sex differences of tear film biomarkers and their roles in health and disease.
• Development of deep learning or bioinformatic approaches for prioritizing, integrating, or analyzing multiple biomarkers for DED.
• Developing new and innovative methodologies, devices, or tools to improve diagnosis and monitoring of dry eye disease.
• Development of lab-on-a-chip systems capable of evaluating multiple biomarkers simultaneously, such as a multiplex tear assay device that incorporates the collection and handling of sub microliter tear volumes.

Application and Submission Information

This notice applies to due dates on or after February 5, 2021 and subsequent receipt dates through May 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-185 - Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196- NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-262 - SBIR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement
• PA-20-261 - STTR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement
• PA-20-260 - SBIR Omnibus/Parent Clinical Trial Not Allowed Funding Opportunity Announcement
• PA-20-265 - STTR Omnibus/Parent Clinical Trial Not Allowed Funding Opportunity Announcement

All instructions in theSF424 (R&R) Application Guide and the FOA used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-EY-21-007” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

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