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

NCT07566975 | Recruiting FDA Drug

• 1 other identifier: HRW-DED-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

patients from a Neuro Ophthalmology who have dry eye, some of which have neurotrophic keratitis are being analyzed after treatment with Vevye

Conditions

Dry Eye

Keywords

Neurotrophic Keratitis; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Corneal fluorescein staining

  pre vs post treatment

  Baseline compared to week 4

Study Arms (2)

Dry Eye without neurotrophic changes

Other: Cyclosporine ophthalmic solution 0.1%

Dry Eye with neurotrophic changes

Other: Cyclosporine ophthalmic solution 0.1%

Interventions

Cyclosporine ophthalmic solution 0.1% OTHER

one drop in both eyes twice a day

Also known as: Vevye

Dry Eye with neurotrophic changes; Dry Eye without neurotrophic changes

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All others
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dry Eye Disease in a Neuro Ophthalmology clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuro-Ophthalmology of Texas: lead
• Harrow Inc: collaborator

Study Sites (1)

Neuro Ophthalmology of TX

Houston, Texas, 77074, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Rosa A. Tang

  Neuro Ophthalmology of TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Perez

CONTACT

12817238593; lperez@neuroeye.com

Rosa A Tang, MD

CONTACT

713-258-0009; lperez@neuroeye.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 6 to 12 months
• Access Criteria: anyone who can access ClinicalTrials.gov

Locations

US (1)