The THINK Study Incidence of Neurotrophic Keratopathy)

Last updated: June 25, 2024
Sponsor: Research Insight LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dry Eye Disease

Clinical Study ID

NCT06482164
20241252
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgicalprocedure) performed within the last 3 months or at any time in the investigator'sclinical 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 theinvestigator, is causing reduced corneal sensitivity

  • Concomitant use of daily contact lenses that, in the best judgment of theinvestigator, 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 fungalinfection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelidsincluding hordeolum/stye).

  • Active, systemic, or local disease condition that causes clinically significantocular 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, severeptosis).

  • Ocular surface abnormality that may compromise the corneal integrity (e.g., priorchemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or theeffect of any other ophthalmic medication that might in the opinion of theinvestigator 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 pregnantduring participation in the study.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Dry Eye Disease
Phase:
Study Start date:
April 05, 2024
Estimated Completion Date:
April 01, 2025

Study 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.

Connect with a study center

  • Harvard Eye Associates

    Laguna Beach, California 92653
    United States

    Active - Recruiting

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