Evaluating corneal sensitivity in patients with dry eye disease
The THINK Study (Testing Hypoesthesia and the Incidence of Neurotrophic Keratopathy)
This study is testing how sensitive the cornea is in people with early Neurotrophic Keratopathy who also have dry eye disease to see if it can help identify those who might need a specific treatment to improve their vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Research Insight LLC Industry-sponsored |
| Locations | 1 site (Laguna Beach, California) |
| Trial ID | NCT06482164 on ClinicalTrials.gov |
What this trial studies
This study aims to assess corneal sensitivity in patients diagnosed with Stage 1 Neurotrophic Keratopathy (NK) who also exhibit signs of dry eye disease (DED). By correlating corneal sensitivity findings with clinical parameters, the study seeks to identify patients who may require future treatment with rhNGF for improved visual performance. The methodology involves a cross-sectional evaluation of patients, focusing on corneal staining and tear break-up time as key indicators of disease severity. The ultimate goal is to enhance understanding of the condition and its impact on patients' quality of vision.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with dry eye disease and exhibiting Stage 1 Neurotrophic Keratopathy.
Not a fit: Patients who have undergone recent ocular surgery or have conditions causing reduced corneal sensitivity unrelated to dry eye disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients who need targeted treatment for improved visual outcomes.
How similar studies have performed: Other studies have shown promise in evaluating corneal sensitivity in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Laguna Beach, California
- Harvard Eye Associates — Laguna Beach, California, United States (Recruiting)
Study contacts
- Principal investigator: John Hovanesian, MD — Harvard Eye Associates
- Study coordinator: Leslie Lemieux
- Email: research@researchinsightca.com
- Phone: 9513884422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.