Trial · NCT02278614
Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
NCT02278614, Phase 3, Completed, Laboratoires Thea; results first posted 2017-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients. Trials, record NCT02278614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02278614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients
- NCT number
- NCT02278614
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 242 participants, actual
- Lead sponsor
- Laboratoires Thea
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Interventions
- T2347, Xalacom
- First posted
- 2014-10-30
- Last updated
- 2017-04-28
- Results first posted
- 2017-01-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye | Day 84 | the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye. Two relevant time points are considered for this primary criteria: D0 and Day 84. |
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 | Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye | Day 84 | The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients).~mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment.~242 patients described in the participant flow correpsond to the ITT \& Safety set. | mm Hg | LEAST_SQUARES_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 |
|---|---|---|---|---|---|
| Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye | T2347 | -0.51 | Standard Error 0.18 | mm Hg | |
| Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye | Xalacom | -0.52 | Standard Error 0.19 | mm Hg |
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 | T2347 | 127 | |
| Overall Study | STARTED | Xalacom | 115 | |
| Overall Study | COMPLETED | T2347 | 122 | |
| Overall Study | COMPLETED | Xalacom | 110 | |
| Overall Study | NOT COMPLETED | T2347 | 5 | |
| Overall Study | NOT COMPLETED | Xalacom | 5 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Cerebral artery occlusion | Nervous system disorders | T2347 | 0 | 127 | 0 |
| serious | Cerebral artery occlusion | Nervous system disorders | Xalacom | 1 | 115 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T2347 | ||
| Total, all-cause mortality | Xalacom | ||
| Total, other adverse events | T2347 | 0 | 127 |
| Total, other adverse events | Xalacom | 0 | 115 |
| Total, serious adverse events | T2347 | 0 | 127 |
| Total, serious adverse events | Xalacom | 1 | 115 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| T2347 vs Xalacom: serious adverse events |
Source 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/NCT02278614
GET https://conductscience.org/api/trials/v1/NCT02278614/registered