Trial · NCT01191008
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
NCT01191008, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2017-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension. Trials, record NCT01191008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191008
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
- NCT number
- NCT01191008
- Status
- Completed
- Enrollment
- 661 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Glaucoma, Ocular Hypertension
- Interventions
- Latanoprost-timolol maleate fixed combination ophthalmic solution
- First posted
- 2010-08-30
- Last updated
- 2023-06-01
- Results first posted
- 2017-07-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants WithTreatment-Related Adverse Events | Max 104 weeks | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator. |
| Primary | Clinical Effectiveness Rate | Max 104 weeks | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks). |
| Other | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Max 104 weeks | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants WithTreatment-Related Adverse Events | Max 104 weeks | The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once. | Participants | NUMBER |
| PRIMARY | Clinical Effectiveness Rate | Max 104 weeks | The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Max 104 weeks | The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants WithTreatment-Related Adverse Events | Latanoprost/Timolol Maleate | 73 | Participants | ||
| Clinical Effectiveness Rate | Latanoprost/Timolol Maleate | 82.8 | 95% Confidence Interval 79.6 to 85.7 | Percentage of participants | |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Latanoprost/Timolol Maleate | 3 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Latanoprost/Timolol Maleate | 633 | |
| Overall Study | COMPLETED | Latanoprost/Timolol Maleate | 618 | |
| Overall Study | NOT COMPLETED | Latanoprost/Timolol Maleate | 15 |
Source ClinicalTrials.gov
Adverse events64
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 | Conjunctivitis | Infections and infestations | Latanoprost/Timolol Maleate | 11 | 618 | |
| other | Conjunctivitis bacterial | Infections and infestations | Latanoprost/Timolol Maleate | 1 | 618 | |
| other | Visual field defect | Nervous system disorders | Latanoprost/Timolol Maleate | 2 | 618 | |
| other | Uveitis | Eye disorders | Latanoprost/Timolol Maleate | 3 | 618 | |
| other | Conjunctivitis allergic | Eye disorders | Latanoprost/Timolol Maleate | 14 | 618 | |
| other | Meibomian gland dysfunction | Eye disorders | Latanoprost/Timolol Maleate | 1 | 618 | |
| other | Age-related macular degeneration | Eye disorders | Latanoprost/Timolol Maleate | 1 | 618 | |
| other | Corneal erosion | Eye disorders | Latanoprost/Timolol Maleate | 5 | 618 | |
| other | Keratitis | Eye disorders | Latanoprost/Timolol Maleate | 1 | 618 | |
| other | Corneal disorder | Eye disorders | Latanoprost/Timolol Maleate | 9 | 618 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Latanoprost/Timolol Maleate | ||
| Total, other adverse events | Latanoprost/Timolol Maleate | 134 | 618 |
| Total, serious adverse events | Latanoprost/Timolol Maleate | 13 | 618 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01191008
GET https://conductscience.org/api/trials/v1/NCT01191008/events?page=2