VEVYE (cyclosporine 0.1%) for short-term symptom and sign improvement in dry eye at a neuro-ophthalmology clinic

Real-World Assessment of VEVYE® for Short-Term Symptom and Sign Improvement of Dry Eye Disease in a Neuro-Ophthalmology Clinic: A 6-Month Prospective Observational Study

This project will test whether VEVYE (cyclosporine 0.1% eye drops) improves symptoms and clinical signs in adults with dry eye disease seen in a neuro-ophthalmology clinic, including some people with neurotrophic keratitis.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Neuro-Ophthalmology of Texas (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07566975 on ClinicalTrials.gov

What this trial studies

This is a 6-month prospective observational follow-up of adults seen in a neuro-ophthalmology clinic who are prescribed VEVYE as part of routine care for clinically diagnosed dry eye (OSDI ≥23 and at least one objective sign). Patients receive topical cyclosporine 0.1% per their treating clinician and complete standardized symptom questionnaires and clinic assessments at baseline and scheduled follow-ups. The non-randomized design captures real-world treatment patterns and includes a subgroup with neurotrophic keratitis. Outcomes focus on short-term changes in patient-reported symptoms and objective ocular surface signs.

Who should consider this trial

Good fit: Adults (≥18 years) with a clinical diagnosis of dry eye disease, OSDI ≥23, at least one objective sign, and who are indicated for VEVYE and able to attend visits and complete questionnaires are ideal candidates.

Not a fit: Patients with active corneal ulcers, severe ocular surface infection or unrelated severe surface disease, recent ocular surgery, severe corneal scarring or zero corneal sensitivity, or recent use of other cyclosporine/lifitegrast products are unlikely to benefit in this short-term observational context.

Why it matters

Potential benefit: If successful, this could offer real-world evidence that VEVYE reduces symptoms and improves ocular surface signs in patients with dry eye, including some with neurotrophic corneal disease.

How similar studies have performed: Other topical cyclosporine formulations have shown benefit for dry eye symptoms and signs in randomized trials, but evidence specifically for VEVYE 0.1% and for patients with neurotrophic keratitis is limited.

Eligibility criteria

Inclusion Criteria:

* Age18 yr or older Diagnosis of neuro-ophthalmic condition Clinical diagnosis of dry eye disease OSDI score of 23 or greater at baseline Objective sign present Indicated for VEVYE prior to enrollment Ability and willingness to complete study visits and questionnaires

Exclusion Criteria:

* Patients with a corneal ulcer Use of another cyclosporine or lifitegrast product within 30 days of baseline Ocular surgery within 30 prior to baseline Active ocular infection or severe ocular surface condition unrelated to DED Contact lens wearers ( must be off contacts for 30 days and the duration of trial) Any condition that prevents compliance or informed consent Subjects with severe scarring / zero sensitivity

Where this trial is running

Houston, Texas

• Neuro Ophthalmology of TX — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Rosa A. Tang — Neuro Ophthalmology of TX
• Study coordinator: Laura Perez

Conditions Dry Eye; Neurotrophic Keratitis