Dry EyeNCT07566975
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
An observational study of Dry Eye, run by Neuro-Ophthalmology of Texas at 1 site in United States.
Trial summary
patients from a Neuro Ophthalmology who have dry eye, some of which have neurotrophic keratitis are being analyzed after treatment with Vevye Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Cyclosporine ophthalmic solution 0.1%
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dry Eye Disease in a Neuro Ophthalmology clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuro Ophthalmology of TX
Houston, Texas, 77074
Laura Perez, 2817238593, lperez@neuroeye.com
Rosa A Tang, MD, 7132580009, rosatang.md@me.com
About this study
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
- Being tested
- Cyclosporine ophthalmic solution 0.1%
- Keywords
- Neurotrophic Keratitis, Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ophthalmic solution 0.1%Other
Also called Vevye
one drop in both eyes twice a day
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye without neurotrophic changes | Not described Receives: Other: Cyclosporine ophthalmic solution 0.1% | |
| Dry Eye with neurotrophic changes | Not described Receives: Other: Cyclosporine ophthalmic solution 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining
pre vs post treatment
Measured: Baseline compared to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start31 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuro-Ophthalmology of Texas
- Sponsor type
- University, hospital or other
- Collaborators
- Harrow Inc
- Responsible party
- Sponsor
- Investigators
- Rosa A. Tang, Principal investigator, Neuro Ophthalmology of TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566975
- Sponsor's protocol ID
- HRW-DED-001
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: results of pre and post treatment data
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07566975
- Acronym / sponsor ID
- HRW-DED-001
- Conditions
- Dry Eye
- Keywords
- Neurotrophic Keratitis, Dry Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neuro-Ophthalmology of TexasUniversity, hospital or other
- Collaborators
- Harrow Inc
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
patients from a Neuro Ophthalmology who have dry eye, some of which have neurotrophic keratitis are being analyzed after treatment with Vevye
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye without neurotrophic changes | – | Other: Cyclosporine ophthalmic solution 0.1% |
| Dry Eye with neurotrophic changes | – | Other: Cyclosporine ophthalmic solution 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dry Eye Disease in a Neuro Ophthalmology clinic
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine ophthalmic solution 0.1%Also: Vevyeone drop in both eyes twice a day | Other | Dry Eye with neurotrophic changes, Dry Eye without neurotrophic changes |
Primary outcome
Corneal fluorescein staining
Time frame: Baseline compared to week 4
pre vs post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. results of pre and post treatment data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosa A. Tang principal investigator
Neuro Ophthalmology of TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Neuro-Ophthalmology of Texas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Perez (12817238593, lperez@neuroeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal fluorescein staining (time frame: Baseline compared to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.