GlaucomaEarly Phase 1NCT07425535
Optic Nerve Head Strain in Non-glaucoma Subjects
A Early Phase 1 study testing Latanoprost (0.005%) in people with Glaucoma, run by Johns Hopkins University at 1 site in United States.
Trial summary
Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost (0.005%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2026to 31 Mar 2028
- Phase
- Early Phase 1
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults who have no history of OAG
- Have an ocular examination by a glaucoma specialist with no indications of OAG
- Have normal optical coherence tomography findings in the retinal nerve fiber layer.
- Over age 30 will be included from
- Both sexes
- All ethnic groups.
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- Optic neuropathy.
- Both suspects and those with glaucoma damage will be included.
- When both eyes meet inclusion and exclusion criteria, both eyes will be included in the study and statistical methods will be used to account for correlations between eyes within the same individual.
Who cannot join
- in whom sitting in an upright position is impossible due to physical disability
- with ocular media opacity, corneal scarring, cataract or vitreous hemorrhage, that does not allow adequate imaging resolution.
- in whom keeping the eyes open during the imaging procedure is not possible or uncomfortable.
- who cannot perform home tonometry accurately at certification
- who do not have reliable clinical Optical Coherence Tomography (OCT) testing.
- with any form of glaucoma
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- with high myopia defined as refractive error > -8
- with past keratorefractive surgery, corneal dystrophy, or corneal ectasia that would make self-tonometry measurements difficult to interpret
- inability to understand English or with a language or hearing impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Farzaneh Dadvar, MD contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Harry Quigley, 443-742-7079, hquigley@jhmi.edu
Farzaneh Dadvar, 4103954535, fdadvar1@jh.edu
About this study
Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.
Read the detailed description
The present proposal seeks to measure biomechanical strains in age-matched control subjects who do not have Open-angle Glaucoma (OAG), using the same non-invasive imaging methods as in the above programs. This is necessary as even undamaged OAG eyes may have different biomechanical properties at baseline than do non-OAG eyes. While there are some limited methods to test strains in control eyes, to compare normal to OAG responses robustly, the same methods of changing intra-ocular pressure (IOP) must be applied-namely to lower IOP by delivery of FDA-approved agent, latanoprost, as has been done in the investigator's OAG subjects. The method of measuring strain requires images taken at two different IOP levels.
- Conditions
- Glaucoma
- Being tested
- Latanoprost (0.005%)
- Keywords
- optic nerve, biomechanical strain, normal eye, glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost (0.005%)Drug
Participants take the eye drop daily for less than one month
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The participants will take an approved glaucoma eye drop, latanoprost, for less than one month, with pictures of the eyes at baseline and while taking the drop. Receives: Drug: Latanoprost (0.005%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head strain
Biomechanical strain measured by optical coherence tomography
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start24 Jun 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Harry Quigley, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425535
- Sponsor's protocol ID
- IRB00541877
- Other IDs
- R01EY036042
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Strain in Non-glaucoma Subjects
- ClinicalTrials.gov ID
- NCT07425535
- Acronym / sponsor ID
- IRB00541877
- Conditions
- Glaucoma
- Keywords
- optic nerve, biomechanical strain, normal eye, glaucoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 23 Feb 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.
Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.
Detailed description
The present proposal seeks to measure biomechanical strains in age-matched control subjects who do not have Open-angle Glaucoma (OAG), using the same non-invasive imaging methods as in the above programs. This is necessary as even undamaged OAG eyes may have different biomechanical properties at baseline than do non-OAG eyes. While there are some limited methods to test strains in control eyes, to compare normal to OAG responses robustly, the same methods of changing intra-ocular pressure (IOP) must be applied-namely to lower IOP by delivery of FDA-approved agent, latanoprost, as has been done in the investigator's OAG subjects. The method of measuring strain requires images taken at two different IOP levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Latanoprost (0.005%)The participants will take an approved glaucoma eye drop, latanoprost, for less than one month, with pictures of the eyes at baseline and while taking the drop. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults who have no history of OAG
- Have an ocular examination by a glaucoma specialist with no indications of OAG
- Have normal optical coherence tomography findings in the retinal nerve fiber layer.
- Over age 30 will be included from
- Both sexes
Key exclusion criteria (9 listed)
- in whom sitting in an upright position is impossible due to physical disability
- with ocular media opacity, corneal scarring, cataract or vitreous hemorrhage, that does not allow adequate imaging resolution.
- in whom keeping the eyes open during the imaging procedure is not possible or uncomfortable.
- who cannot perform home tonometry accurately at certification
- who do not have reliable clinical Optical Coherence Tomography (OCT) testing.
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 |
|---|---|---|
| Latanoprost (0.005%)Participants take the eye drop daily for less than one month | Drug | Study group |
Primary outcome
Optic nerve head strain
Time frame: up to 1 month
Biomechanical strain measured by optical coherence tomography
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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Farzaneh Dadvar, MD contact
Harry Quigley, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Latanoprost (0.005%) in people with Glaucoma, run by Johns Hopkins University 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 9 inclusion and 9 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 13 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Harry A Quigley, MD (410 955 6051, hquigley@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve head strain (time frame: up to 1 month). 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 13 Jul 2026.