Trial · NCT03825380
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
NCT03825380, Phase 3, Completed, Laboratoires Thea; results first posted 2023-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients. Trials, record NCT03825380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03825380
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
- NCT number
- NCT03825380
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 485 participants, actual
- Lead sponsor
- Laboratoires Thea
- Conditions
- Ocular Hypertension, Glaucoma
- Interventions
- Bimatoprost, Lumigan®
- First posted
- 2019-01-31
- Last updated
- 2023-11-21
- Results first posted
- 2023-11-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intra-Ocular Pressure | Week 12 | Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intra-Ocular Pressure | Week 12 | Modified Intent To Treat | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intra-Ocular Pressure | T4032 | -9.67 | Standard Error 0.19 | mmHg | |
| Intra-Ocular Pressure | Lumigan® | -9.50 | Standard Error 0.18 | mmHg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T4032 | 236 | |
| Overall Study | STARTED | Lumigan® | 249 | |
| Overall Study | COMPLETED | T4032 | 218 | |
| Overall Study | COMPLETED | Lumigan® | 227 | |
| Overall Study | NOT COMPLETED | T4032 | 18 | |
| Overall Study | NOT COMPLETED | Lumigan® | 22 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | T4032 | 13 | 236 | 13 |
| other | Conjunctival hyperaemia | Eye disorders | Lumigan® | 17 | 249 | 17 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | T4032 | 1 | 236 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Lumigan® | 0 | 249 | 0 |
| serious | Cholecystitis acute | Hepatobiliary disorders | T4032 | 0 | 236 | 0 |
| serious | Cholecystitis acute | Hepatobiliary disorders | Lumigan® | 1 | 249 | 1 |
| serious | Pneumonia | Infections and infestations | T4032 | 0 | 236 | 0 |
| serious | Pneumonia | Infections and infestations | Lumigan® | 1 | 249 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T4032 | 0 | 236 |
| Total, all-cause mortality | Lumigan® | 0 | 249 |
| Total, other adverse events | T4032 | 13 | 236 |
| Total, other adverse events | Lumigan® | 17 | 249 |
| Total, serious adverse events | T4032 | 1 | 236 |
| Total, serious adverse events | Lumigan® | 2 | 249 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| T4032 vs Lumigan®: deaths from any cause | Trial comparisons |
| T4032 vs Lumigan®: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03825380
GET https://conductscience.org/api/trials/v1/NCT03825380/registered