GlaucomaPhase 4NCT04412096
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
A Phase 4 study testing Timolol 0.5% ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma and OHT - Ocular Hypertension, run by Ohio State University at 3 sites in United States.
Trial summary
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma, OHT - Ocular Hypertension
- What is being tested?
- Timolol 0.5% ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Nov 2020to 22 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any self-declared ethnicity-race
- Open-angle with one of the following:
- Untreated OHT ≥ 21mmHg
- Treated OHT with history of IOP ≥ 21 mmHg on 2 prior clinic visits or IOP ≥ 21 mmHg at screening
- Mild-to-moderate stage open-angle glaucoma based on history of untreated IOP ≥ 21 mmHg
- Reliable Humphrey visual field test result within previous 1 year
Show all 13Show fewer
- Open on gonioscopy within previous 1 year
- At least one eye must be phakic
- Able to cooperate for aqueous humor dynamic procedures
- Able to participate on site over the multi-visit study period
- Contact lenses must be removed before topical fluorescein instillation and remain out until study testing the following day is completed.
- Contact lenses must be removed for the entire duration of the study visits.
- All study medication must be used without contact lenses in the eyes.
Who cannot join
- Women who are pregnant or breastfeeding
- IOP ≥ 38 in study eye(s) or at discretion of the clinician
- Refusal to remove contact lenses
- Advanced visual field loss (MD ≤ -16 dB) or threat to fixation in study eye(s) or at discretion of the clinician
- Study eye(s) with any sign of Fuchs cornea dystrophy as noted clinically with guttae and corneal edema
- Narrow angle of ≤ Shaffer grade 2 for 180 degrees, peripheral synechiae, or peripheral iridotomy in either eye
Show all 23Show fewer
- History of acute angle closure crisis in either eye
- History of glaucoma incisional surgery (e.g., trabeculectomy, glaucoma drainage implant, Xen gel stent) in study eye(s)
- History of minimally invasive glaucoma surgery (MIGS, e.g., angle surgery, Cypass) in study eye(s)
- History of any cycloablation surgery (e.g., micropulse or diode transcleral or endoscopic cyclophotocoagulation) in study eye(s)
- Study eye cannot have history of any past SLT or ALT glaucoma laser treatments.
- Study eye(s) cannot have any history of refractive surgery
- Study eye(s) cannot have any history of herpetic infection of the cornea
- Study eye(s) cannot have chronic or recurrent inflammatory eye disease
- Study eye(s) cannot have ocular trauma within the past 6 months, other than uncomplicated cornea abrasion
- Study eye(s) cannot have ocular infection in the past 3 months
- Study eye(s) cannot have clinically significant retinal disease that includes proliferative diabetic retinopathy, vein occlusion, cystoid macular edema, wet age-related macular degeneration
- History of intraocular or peri-ocular injections in study eye(s) within 3 months
- History of oral steroid use within 30 days of screening Visit 1
- Any abnormality preventing reliable fluorophotometry (e.g., corneal scarring or severe dry eye with fluorescein staining)
- Serious hypersensitivity to any components of study medications or risk from treatment (e.g., sulfa drug allergy, bradycardia, severe asthma, or emphysema)
- Participants must be on minimum 30-day stable regimen prior to Visit 1 for a systemic medication that may affect IOP (i.e., sympathomimetics, beta-blockers, alpha-adrenergic agonists and blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such medication during the study will result in exclusion.
- Prohibited meds during study: cannabis products, brimonidine 0.025% (Lumify), bimatoprost 0.03% for eyelash growth (Latisse), topical ocular and peri-ocular steroids, oral steroids
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University
Columbus, Ohio, 43212
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and-error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.
Read the detailed description
This proposal responded to PA-18-351 "Human Subjects Mechanistic and Minimal Risk Studies" and qualifies as a clinical trial. The central hypothesis is that variations in IOP response to glaucoma drugs and IOP fluctuation can be predicted by the aqueous humor dynamic (AHD) factors that regulate IOP. This hypothesis will be tested in up to 200 participants with ocular hypertension (OHT) or open-angle glaucoma (OAG). This hypothesis will be tested in two aims: Aim 1, Test the hypothesis that AHD factors predict the IOP drug response; Aim 2, Test the hypothesis that aqueous flow and outflow facility predict IOP fluctuation.
The objective is to determine which AHD factors predict a participant's IOP drug response and IOP fluctuation. The scientific rationale is that AHD parameters (aqueous flow, outflow facility, episcleral venous pressure, and uveoscleral flow) determine drug response and IOP fluctuation.
The primary endpoint is IOP response to glaucoma drugs. Exploratory outcome measures include IOP fluctuation and the AHD measures.
The study population includes participants who have either OHT or OAG. The inclusion and exclusion criteria described in 5.3, Study Population. The goal is to recruit 150-200 participants over 4 years.
All drugs and instruments used in this study have been FDA approved.
Three sites will enroll participants: Mayo Clinic, The Ohio State University, and University of Nebraska Medical Center. All sites have experience and expertise with AHD studies in humans. These study team members have productive collaborations during AHD studies in controls during the prior NIH funding period. There are no sites outside of the United States.
The experimental design is a prospective, open-label, clinical trial with randomized cross over treatment using the topical glaucoma medications, timolol 0.5% and latanoprost 0.005%. Timolol 0.5% is a beta-blocker and will be dosed as one drop two times a day. Latanoprost 0.005% is a prostaglandin analogue and will be dosed as one drop daily in the evening. The treatment order will depend on randomization.
AHD measurements are performed at baseline without glaucoma medications. The AHD measurements include IOP, aqueous humor flow, outflow facility, and episcleral venous pressure. Uveoscleral outflow is calculated. Some participants who are already taking glaucoma medications will be washed out in order to assess baseline AHD measurements. An IOP safety check will be scheduled for those who are washed out of their glaucoma Rx. After baseline AHD measurements, the AHD measurements are repeated after each of the 7-day drug interventions to determine the effect of the drug treatment on AHD variables.
There are six study visits, Visits 1 - 6, that include clinical testing, surveys, and AHD procedures (see 1.2 Schema). Participants will be trained to use the Icare® HOME tonometer to measure IOP outside of clinic to assess IOP fluctuation.
The study design is a prospective, open-label, randomized order of 7-days treatments with timolol 0.5% (1 drop two times daily) followed by a washout period and then with latanoprost 0.005% (1 drop daily in the evening) or vice versa. These are referred to as Tx 1 and Tx 2. IOP safety checks during washout are included for those already taking glaucoma Rx upon entering the study. IOP response will be determined to each of these medications. AHD factors will be determined for both study treatments using tonometry, fluorophotometry, tonography, and episcleral venomanometry. IOP fluctuation will be assessed using the FDA-approved Icare® HOME tonometer. All test procedures and drugs are FDA approved. There are no experimental tests or agents.
Sample sizes and power calculations provide rigor to test the hypothesis.
A REDCap database is populated from data on case report forms (CRF), surveys, and the Icare® HOME tonometer. Data will be analyzed using descriptive statistics of central tendencies and dispersion, and regression methods in order to understand the individual data in the distribution of the cohort.
- Conditions
- Glaucoma, OHT - Ocular Hypertension
- Being tested
- Timolol 0.5% ophthalmic solution, Latanoprost 0.005% Ophthalmic Solution
- Keywords
- aqueous humor dynamics, glaucoma, eye diseases, timolol, latanoprost, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, neurotransmitter agents, molecular mechanisms of pharmacological action, physiological effects of drugs, anti-arrhythmia agents, anti-hypertensive agents
- Medical subject headings
- Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol 0.5% ophthalmic solutionDrug
1 drop BID
Latanoprost 0.005% Ophthalmic SolutionDrug
1 drop QD
| Study group | Role | What they receive |
|---|---|---|
| Timolol 0.5% | Experimental | To compare the variation in response to timolol between individuals Receives: Drug: Timolol 0.5% ophthalmic solution |
| Latanoprost 0.005% | Experimental | To compare the variation in response to latanoprost between individuals Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in eye pressures between individuals
Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.
Measured: measurement after 1 week of treatment
Secondary outcomes (2)
Variation in aqueous flow between individuals
Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.
Measured: measurement 1 week after treatment
Variation in episcleral venous pressure
Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.
Measured: measurement 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start23 Nov 2020
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The overall study design is a prospective, open-label, randomized clinical trial with randomized order of 7-day treatments with timolol followed by a washout period and then with latanoprost or vice versa. Participants will undergo two 7-day treatments, with timolol 0.5% (1 drop two times daily) and latanoprost 0.005% (1 drop daily in the evening). The order of timolol and latanoprost will be randomized. The IOP, AHD parameters and IOP fluctuation will be compared in an individual under three conditions: (i) baseline, and after a randomized order of 7-day treatment of (ii) timolol 0.5% 1 drop two times daily and (iii) latanoprost 0.005% 1 drop in the evening separated by a 6-week washout period. The overall time commitment to complete these procedures is three to four months.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, National Eye Institute (NEI), Mayo Clinic
- Responsible party
- Principal investigator, Sayoko Moroi, Ohio State University
- Investigators
- Sayoko Moroi, MD, PhD, Principal investigator, Professor and Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412096
- Sponsor's protocol ID
- 2020H0284
- Other IDs
- R01EY022124
- Status last verified
- Mar 2026
- First submitted
- 29 May 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Man X, Costa R, Ayres BM, Moroi SE. Acetazolamide-Induced Bilateral Ciliochoroidal Effusion Syndrome in Plateau Iris Configuration. Am J Ophthalmol Case Rep. 2016 Oct;3:14-17. doi: 10.1016/j.ajoc.2016.05.003. Epub 2016 May 17.
PubMed 29226268Kazemi A, Reitinger JC, Toris CB, Gulati V, Fan S, Reed DM, Moroi SE, Sit AJ. Aqueous Humor Dynamics Changes and Predictors of IOP Response to Latanoprost in Healthy Subjects. J Glaucoma. 2025 Dec 1;34(12):1056-1064. doi: 10.1097/IJG.0000000000002585. Epub 2025 May 9.
PubMed 40341017
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
- ClinicalTrials.gov ID
- NCT04412096
- Acronym / sponsor ID
- 2020H0284
- Conditions
- Glaucoma, OHT - Ocular Hypertension
- Keywords
- aqueous humor dynamics, glaucoma, eye diseases, timolol, latanoprost, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska, National Eye Institute (NEI), Mayo Clinic
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 2 Jun 2020 (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.
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to medications is a critical barrier for the clinician to consistently provide highly effective IOP-based treatments. Current trial-and-error approaches to glaucoma management are inefficient and have not addressed this barrier as there are no predictive factors for drug response. Our long-term goal is to improve outcomes by identifying biomarkers and environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of this research project is to address this critical barrier by focusing on physiological factors that predict IOP response to drugs.
Detailed description
This proposal responded to PA-18-351 "Human Subjects Mechanistic and Minimal Risk Studies" and qualifies as a clinical trial. The central hypothesis is that variations in IOP response to glaucoma drugs and IOP fluctuation can be predicted by the aqueous humor dynamic (AHD) factors that regulate IOP. This hypothesis will be tested in up to 200 participants with ocular hypertension (OHT) or open-angle glaucoma (OAG). This hypothesis will be tested in two aims: Aim 1, Test the hypothesis that AHD factors predict the IOP drug response; Aim 2, Test the hypothesis that aqueous flow and outflow facility predict IOP fluctuation.
The objective is to determine which AHD factors predict a participant's IOP drug response and IOP fluctuation. The scientific rationale is that AHD parameters (aqueous flow, outflow facility, episcleral venous pressure, and uveoscleral flow) determine drug response and IOP fluctuation.
The primary endpoint is IOP response to glaucoma drugs. Exploratory outcome measures include IOP fluctuation and the AHD measures.
The study population includes participants who have either OHT or OAG. The inclusion and exclusion criteria described in 5.3, Study Population. The goal is to recruit 150-200 participants over 4 years.
All drugs and instruments used in this study have been FDA approved.
Three sites will enroll participants: Mayo Clinic, The Ohio State University, and University of Nebraska Medical Center. All sites have experience and expertise with AHD studies in humans. These study team members have productive collaborations during AHD studies in controls during the prior NIH funding period. There are no sites outside of the United States.
The experimental design is a prospective, open-label, clinical trial with randomized cross over treatment using the topical glaucoma medications, timolol 0.5% and latanoprost 0.005%. Timolol 0.5% is a beta-blocker and will be dosed as one drop two times a day. Latanoprost 0.005% is a prostaglandin analogue and will be dosed as one drop daily in the evening. The treatment order will depend on randomization.
AHD measurements are performed at baseline without glaucoma medications. The AHD measurements include IOP, aqueous humor flow, outflow facility, and episcleral venous pressure. Uveoscleral outflow is calculated. Some participants who are already taking glaucoma medications will be washed out in order to assess baseline AHD measurements. An IOP safety check will be scheduled for those who are washed out of their glaucoma Rx. After baseline AHD measurements, the AHD measurements are repeated after each of the 7-day drug interventions to determine the effect of the drug treatment on AHD variables.
There are six study visits, Visits 1 - 6, that include clinical testing, surveys, and AHD procedures (see 1.2 Schema). Participants will be trained to use the Icare® HOME tonometer to measure IOP outside of clinic to assess IOP fluctuation.
The study design is a prospective, open-label, randomized order of 7-days treatments with timolol 0.5% (1 drop two times daily) followed by a washout period and then with latanoprost 0.005% (1 drop daily in the evening) or vice versa. These are referred to as Tx 1 and Tx 2. IOP safety checks during washout are included for those already taking glaucoma Rx upon entering the study. IOP response will be determined to each of these medications. AHD factors will be determined for both study treatments using tonometry, fluorophotometry, tonography, and episcleral venomanometry. IOP fluctuation will be assessed using the FDA-approved Icare® HOME tonometer. All test procedures and drugs are FDA approved. There are no experimental tests or agents.
Sample sizes and power calculations provide rigor to test the hypothesis.
A REDCap database is populated from data on case report forms (CRF), surveys, and the Icare® HOME tonometer. Data will be analyzed using descriptive statistics of central tendencies and dispersion, and regression methods in order to understand the individual data in the distribution of the cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The overall study design is a prospective, open-label, randomized clinical trial with randomized order of 7-day treatments with timolol followed by a washout period and then with latanoprost or vice versa. Participants will undergo two 7-day treatments, with timolol 0.5% (1 drop two times daily) and latanoprost 0.005% (1 drop daily in the evening). The order of timolol and latanoprost will be randomized. The IOP, AHD parameters and IOP fluctuation will be compared in an individual under three conditions: (i) baseline, and after a randomized order of 7-day treatment of (ii) timolol 0.5% 1 drop two times daily and (iii) latanoprost 0.005% 1 drop in the evening separated by a 6-week washout period. The overall time commitment to complete these procedures is three to four months.
| Arm | Type | Receives |
|---|---|---|
| Timolol 0.5% | Experimental | Drug: Timolol 0.5% ophthalmic solutionTo compare the variation in response to timolol between individuals |
| Latanoprost 0.005% | Experimental | Drug: Latanoprost 0.005% Ophthalmic SolutionTo compare the variation in response to latanoprost between individuals |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Any self-declared ethnicity-race
- Open-angle with one of the following:
- Reliable Humphrey visual field test result within previous 1 year
- Open on gonioscopy within previous 1 year
- At least one eye must be phakic
Key exclusion criteria (23 listed)
- Women who are pregnant or breastfeeding
- IOP ≥ 38 in study eye(s) or at discretion of the clinician
- Refusal to remove contact lenses
- Advanced visual field loss (MD ≤ -16 dB) or threat to fixation in study eye(s) or at discretion of the clinician
- Study eye(s) with any sign of Fuchs cornea dystrophy as noted clinically with guttae and corneal edema
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 |
|---|---|---|
| Timolol 0.5% ophthalmic solution1 drop BID | Drug | Timolol 0.5% |
| Latanoprost 0.005% Ophthalmic Solution1 drop QD | Drug | Latanoprost 0.005% |
Primary outcome
Variation in eye pressures between individuals
Time frame: measurement after 1 week of treatment
Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.
2 secondary outcomes
Variation in aqueous flow between individuals
Time frame: measurement 1 week after treatment
Variation in episcleral venous pressure
Time frame: measurement 1 week after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 29226268Man X, Costa R, Ayres BM, Moroi SE. Acetazolamide-Induced Bilateral Ciliochoroidal Effusion Syndrome in Plateau Iris Configuration. Am J Ophthalmol Case Rep. 2016 Oct;3:14-17. doi: 10.1016/j.ajoc.2016.05.003. Epub 2016 May 17.
- Derived from this study: PubMed 40341017Kazemi A, Reitinger JC, Toris CB, Gulati V, Fan S, Reed DM, Moroi SE, Sit AJ. Aqueous Humor Dynamics Changes and Predictors of IOP Response to Latanoprost in Healthy Subjects. J Glaucoma. 2025 Dec 1;34(12):1056-1064. doi: 10.1097/IJG.0000000000002585. Epub 2025 May 9.
- 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. This study is not recruiting at the moment.
Sayoko Moroi, MD, PhD principal investigator
Professor and Chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timolol 0.5% ophthalmic solution and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma and OHT - Ocular Hypertension, run by Ohio State University at 3 sites 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 13 inclusion and 23 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: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in eye pressures between individuals (time frame: measurement after 1 week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04412096, which also lists 2 linked publications.
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 4 Mar 2026.