Trial Outcomes & Findings for Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension (NCT NCT06394973)

Last Updated: 2026-01-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

161 participants

Primary outcome timeframe

The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.

Results posted on

2026-01-02

Participant Flow

161 patients randomized and 159 patients treated. 2 Patients did not receive a treatment due to randomization error in IRT.

Participant milestones

Participant milestones
Measure	T4090 0.2% Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution.	T4090 0.3% Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution.	Rhopressa® Preserved netarsudil 0.02%, ophthalmic solution.
Overall Study STARTED	53	53	53
Overall Study COMPLETED	48	48	49
Overall Study NOT COMPLETED	5	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T4090 0.2% n=53 Participants Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution.	T4090 0.3% n=53 Participants Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution.	Rhopressa® n=53 Participants Preserved netarsudil 0.02%, ophthalmic solution	Total n=159 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=228 Participants	15 Participants n=115 Participants	12 Participants n=343 Participants	36 Participants n=18 Participants
Age, Categorical >=65 years	44 Participants n=228 Participants	38 Participants n=115 Participants	41 Participants n=343 Participants	123 Participants n=18 Participants
Age, Continuous	71.4 years STANDARD_DEVIATION 9.37 • n=228 Participants	69.2 years STANDARD_DEVIATION 9.45 • n=115 Participants	70.3 years STANDARD_DEVIATION 10.15 • n=343 Participants	70.3 years STANDARD_DEVIATION 9.64 • n=18 Participants
Sex: Female, Male Female	23 Participants n=228 Participants	31 Participants n=115 Participants	26 Participants n=343 Participants	80 Participants n=18 Participants
Sex: Female, Male Male	30 Participants n=228 Participants	22 Participants n=115 Participants	27 Participants n=343 Participants	79 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=228 Participants	11 Participants n=115 Participants	11 Participants n=343 Participants	35 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=228 Participants	42 Participants n=115 Participants	42 Participants n=343 Participants	124 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	2 Participants n=228 Participants	0 Participants n=115 Participants	2 Participants n=343 Participants	4 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=228 Participants	1 Participants n=115 Participants	0 Participants n=343 Participants	1 Participants n=18 Participants
Race (NIH/OMB) Black or African American	9 Participants n=228 Participants	12 Participants n=115 Participants	9 Participants n=343 Participants	30 Participants n=18 Participants
Race (NIH/OMB) White	42 Participants n=228 Participants	40 Participants n=115 Participants	42 Participants n=343 Participants	124 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=228 Participants	0 Participants n=115 Participants	0 Participants n=343 Participants	0 Participants n=18 Participants
Region of Enrollment United States	53 Participants n=228 Participants	53 Participants n=115 Participants	53 Participants n=343 Participants	159 Participants n=18 Participants

PRIMARY outcome

Timeframe: The primary efficacy endpoint is the change from baseline (D1) at Week 7 in the mean diurnal IOP in the study eye.

Population: Primary estimand - Full Set Analysis

Outcome measures

Outcome measures
Measure	T4090 0.2% n=45 Participants Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution.	T4090 0.3% n=42 Participants Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution.	Rhopressa® n=47 Participants Preserved netarsudil 0.02%, ophthalmic solution.
Mean Diurnal IOP	-5.07 mmHg Standard Deviation 2.75	-4.73 mmHg Standard Deviation 2.94	-4.6 mmHg Standard Deviation 3.06

Adverse Events

T4090 0.2%

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

T4090 0.3%

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Rhopressa®

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	T4090 0.2% n=53 participants at risk Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution.	T4090 0.3% n=53 participants at risk Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution.	Rhopressa® n=53 participants at risk Preserved netarsudil 0.02%, ophthalmic solution.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	0.00% 0/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.

Other adverse events

Additional Information

Clinical Affairs Director

Laboratoires Théa

Phone: +33473981436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	T4090 0.2% n=53 participants at risk Preservative-free Kinezodianone R HCl 0.2%, ophthalmic solution.	T4090 0.3% n=53 participants at risk Preservative-free Kinezodianone R HCl 0.3%, ophthalmic solution.	Rhopressa® n=53 participants at risk Preserved netarsudil 0.02%, ophthalmic solution.
Eye disorders Abnormal sensation in eye	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	7.5% 4/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Blepharitis	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Conjunctival haemorrhage	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Conjunctival hyperaemia	66.0% 35/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	47.2% 25/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	39.6% 21/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Corneal endothelial cell loss	11.3% 6/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	15.1% 8/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Corneal endothelial disorder	35.8% 19/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	30.2% 16/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	20.8% 11/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Eye irritation	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Eye pain	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Eye pruritus	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	11.3% 6/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	7.5% 4/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Foreign body sensation in eyes	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Lacrimation increased	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	15.1% 8/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	11.3% 6/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Ocular hyperaemia	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	17.0% 9/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	13.2% 7/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Eye disorders Vision blurred	13.2% 7/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	13.2% 7/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	7.5% 4/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
General disorders Instillation site erythema	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	15.1% 8/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
General disorders Instillation site irritation	7.5% 4/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	15.1% 8/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	18.9% 10/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
General disorders Instillation site lacrimation	9.4% 5/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	3.8% 2/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Investigations Conjunctival staining	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	1.9% 1/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.
Investigations Corneal pachymetry	11.3% 6/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	11.3% 6/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.	5.7% 3/53 • Adverse events were collected from informed consent signature (Visit #1) until the final study visit (Visit #5), up to 53 days.