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The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T4090 0.2% | Experimental |
| |
| T4090 0.3% | Experimental |
| |
| Rhopressa® | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T4090 0.2% | Drug | 1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal IOP | IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints. | The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advanced Eye Research Institute | Glendale | Arizona | 85306 | United States | ||
| Global Research Management, Inc. |
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161 patients randomized and 159 patients treated. 2 Patients did not receive a treatment due to randomization error in IRT.
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| ID | Title | Description |
|---|---|---|
| FG000 | T4090 0.2% | Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution. |
| FG001 | T4090 0.3% | Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2024 | Sep 22, 2025 |
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| T4090 0.3% | Drug | 1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7). |
|
| Rhopressa® | Drug | 1 drop in the conjunctival cul-de-sac of each eye once daily at 8:00 PM (±1 hour) from Day 1 to the day before the End of treatment visit (Visit #5 - Week 7). |
|
| Glendale |
| California |
| 91204 |
| United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Visionary Research Institute | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Sacramento Eye Consultants, A Medical Corporation | Sacramento | California | 95815 | United States |
| Wolstan and Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Segal Drug Trials, Inc | Delray Beach | Florida | 33484 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32256 | United States |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | United States |
| Mild Florida Eye Center | Mt. Dora | Florida | 32757 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Alterman, Modi and Wolter Ophthalmic Surgeons | Poughkeepsie | New York | 12603 | United States |
| James D. Branch, MD | Winston-Salem | North Carolina | 27101 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Keystone Research | Austin | Texas | 78731 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| Houston Eye Associates | Houston | Texas | 53719 | United States |
| Houston Eye Associates | Houston | Texas | 77008 | United States |
| DCT-Shah Research, LLC sba Discovery Clinical Trials | Mission | Texas | 78572 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| FG002 | Rhopressa® | Preserved netarsudil 0.02%, ophthalmic solution. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | T4090 0.2% | Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution. |
| BG001 | T4090 0.3% | Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution. |
| BG002 | Rhopressa® | Preserved netarsudil 0.02%, ophthalmic solution |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age by class | Count of Participants | Participants |
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| Age, Continuous | Age at screening | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Diurnal IOP | IOP measurement with calibrated Goldmann applanation tonometer in each eye at three time points (8:00 AM; 10:00 AM; 4:00 PM) by the Investigator. Mean diurnal is calculated from these three timepoints. | Primary estimand - Full Set Analysis | Posted | Mean | Standard Deviation | mmHg | The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye. |
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Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T4090 0.2% | Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution. | 0 | 53 | 0 | 53 | 46 | 53 |
| EG001 | T4090 0.3% | Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution. | 0 | 53 | 0 | 53 | 46 | 53 |
| EG002 | Rhopressa® | Preserved netarsudil 0.02%, ophthalmic solution. | 0 | 53 | 1 | 53 | 36 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | Non-systematic Assessment |
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| Blepharitis | Eye disorders | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | Non-systematic Assessment |
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| Corneal endothelial cell loss | Eye disorders | Non-systematic Assessment |
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| Corneal endothelial disorder | Eye disorders | Non-systematic Assessment |
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| Eye irritation | Eye disorders | Non-systematic Assessment |
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| Eye pain | Eye disorders | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | Non-systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
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| Vision blurred | Eye disorders | Non-systematic Assessment |
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| Instillation site erythema | General disorders | Non-systematic Assessment |
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| Instillation site irritation | General disorders | Non-systematic Assessment |
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| Instillation site lacrimation | General disorders | Non-systematic Assessment |
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| Conjunctival staining | Investigations | Non-systematic Assessment |
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| Corneal pachymetry | Investigations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Director | Laboratoires Théa | +33473981436 | Corentin.LECAMUS@theapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2025 | Sep 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mean Difference (Final Values) |
| -0.36 |
| 2-Sided |
| Other |