The THINK Study Incidence of Neurotrophic Keratopathy) (THINK)

The THINK Study (Testing Hypoesthesia and the Incidence of Neurotrophic Keratopathy)

The study purpose is to evaluate corneal sensitivity in patients that have Stage 1 Neurotrphic Keratopathy (NK). Identifying patients with Stage 1 NK, may predict those who will in the future require rhNGF for optimal visual performance.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Diagnostic test: Dry Eye Disease

Detailed Description

The purpose of this study is to evaluate corneal sensitivity in a cross-section of patients with signs of dry eye disease (DED), correlating findings against clinical parameters relating to the severity of disease and impact on quality of vision. Identifying those patients with Stage 1 Neurotrophic Keratopathy (NK), i.e. those with corneal staining and reduced sensitivity, may predict those who will in the future require rhNGF for optimal visual performance.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Beach, California, United States, 92653
      • Harvard Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

*Patients with the following: A diagnosis of dry eye disease Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.

• Able to comprehend and sign a statement of informed consent.
• Willing and able to complete all required postoperative visits.

Exclusion Criteria:

• Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
• Evidence of BAK or other chemical toxicity that, in the best judgment of the investigator, is causing reduced corneal sensitivity
• Concomitant use of daily contact lenses that, in the best judgment of the investigator, is causing reduced corneal sensitivity
• Clinically significant ocular trauma.
• Active ocular Herpes simplex or Herpes Zoster infection
• Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
• Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
• Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
• Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
• Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
• Participation in this trial in the same patient's fellow eye
• Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dry Eye Disease; Patients who have signs of dry eye	Diagnostic test: Dry Eye Disease; Corneal sensitivity in patients who also have dry eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with stage 1 neurotrophic keratopathy (NK)	Patients with stage 1 neurotrophic keratopathy NK among dry eye patients	Baseline Visit 0

Collaborators and Investigators

• Sponsor: Research Insight LLC
• Investigators: Principal Investigator: John Hovanesian, MD, Harvard Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): August 7, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 20241252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No