Trial · NCT04910100
Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension
NCT04910100, Phase 2, Completed, Betaliq, Inc.; results first posted 2024-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension. Trials, record NCT04910100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04910100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension
- NCT number
- NCT04910100
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 226 participants, actual
- Lead sponsor
- Betaliq, Inc.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Interventions
- Nebivolol Ophthalmic Suspension 1 Percent, Nebivolol Ophthalmic Suspension 0.5 Percent, Timolol Ophthalmic Suspension 0.5 Percent, Timolol Ophthalmic Solution 0.5 Percent
- First posted
- 2021-06-02
- Last updated
- 2024-04-17
- Results first posted
- 2024-04-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular Pressure Over 84 Days | Over 84 days | Measured utilizing a calibrated Goldmann tonometer; two consecutive IOP measurements of each eye will be performed. If the 2 measurements differ by more than 2 mm Hg, a third measurement will be taken. The primary efficacy analysis will be the between-group comparison of the mean IOP values in the study eye at 10AM, 2 hours postdose, and 4PM, at each of the Visit 4/Day 15, Visit 5/Day 42, and Visit 6/Day 84 visits (ie, a total of 9 between-group comparisons). A hierarchical analysis will be conducted to compare each of the investigational products against the comparator, timolol 0.5% ophthalmic solution, as follows: (1) nebivolol 1% ophthalmic suspension, (2) nebivolol 0.5% ophthalmic suspension, and (3) timolol ophthalmic suspension. |
| Secondary | Intraocular Pressure: Change From Baseline in Diurnal IOP at Each Visit | Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes | Change from baseline (Visit 3/Qualification/Baseline) in the average of the 3 daily IOP measurements at Day 15, Day 42, and Day 84 |
| Secondary | Intraocular Pressure: Change From Baseline at All Time Points at Each Visit | Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes | Time-matched change from baseline (Visit 3/Qualification/Baseline) in the 3 daily IOP measurements at Day 15, Day 42 and Day 84 |
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 | Intraocular Pressure Over 84 Days | Over 84 days | The analysis is performed at 9 different time points and compared to baseline (Visit 3 - Day 1), hence, the numbers analyzed at each time point differs from the overall number due to drop outs | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intraocular Pressure: Change From Baseline in Diurnal IOP at Each Visit | Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes | Study eye for the Per Protocol population | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Intraocular Pressure: Change From Baseline at All Time Points at Each Visit | Day 15: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 42: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes; Day 84: 8 AM ± 30 minutes, 2 hours post-dose ± 30 minutes, 4 PM ± 30 minutes | Study Eye in the Per Protocol population | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 1 Percent | Visit 4 - Day 15 - 8 am | 22.0 | 95% Confidence Interval 21.1 to 23.0 | mmHg |
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 0.5 Percent | Visit 4 - Day 15 - 8 am | 22.5 | 95% Confidence Interval 21.6 to 23.4 | mmHg |
| Intraocular Pressure Over 84 Days | Timolol Ophthalmic Suspension 0.5 Percent | Visit 4 - Day 15 - 8 am | 18.8 | 95% Confidence Interval 17.9 to 19.7 | mmHg |
| Intraocular Pressure Over 84 Days | Timolol Ophthalmic Solution 0.5 Percent | Visit 4 - Day 15 - 8 am | 19.4 | 95% Confidence Interval 18.5 to 20.3 | mmHg |
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 1 Percent | Visit 4 - Day 15 - 10 am | 20.4 | 95% Confidence Interval 19.5 to 21.2 | mmHg |
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 0.5 Percent | Visit 4 - Day 15 - 10 am | 21.1 | 95% Confidence Interval 20.3 to 21.9 | mmHg |
| Intraocular Pressure Over 84 Days | Timolol Ophthalmic Suspension 0.5 Percent | Visit 4 - Day 15 - 10 am | 17.7 | 95% Confidence Interval 16.9 to 18.5 | mmHg |
| Intraocular Pressure Over 84 Days | Timolol Ophthalmic Solution 0.5 Percent | Visit 4 - Day 15 - 10 am | 17.9 | 95% Confidence Interval 17.1 to 18.8 | mmHg |
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 1 Percent | Visit 4 - Day 15 - 4 pm | 19.8 | 95% Confidence Interval 18.9 to 20.6 | mmHg |
| Intraocular Pressure Over 84 Days | Nebivolol Ophthalmic Suspension 0.5 Percent | Visit 4 - Day 15 - 4 pm | 20.6 | 95% Confidence Interval 19.8 to 21.4 | mmHg |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebivolol Ophthalmic Suspension 1 Percent | 54 | |
| Overall Study | STARTED | Nebivolol Ophthalmic Suspension 0.5 Percent | 58 | |
| Overall Study | STARTED | Timolol Ophthalmic Suspension 0.5 Percent | 56 | |
| Overall Study | STARTED | Timolol Ophthalmic Solution 0.5 Percent | 58 | |
| Overall Study | COMPLETED | Nebivolol Ophthalmic Suspension 1 Percent | 49 | |
| Overall Study | COMPLETED | Nebivolol Ophthalmic Suspension 0.5 Percent | 51 | |
| Overall Study | COMPLETED | Timolol Ophthalmic Suspension 0.5 Percent | 55 | |
| Overall Study | COMPLETED | Timolol Ophthalmic Solution 0.5 Percent | 54 | |
| Overall Study | NOT COMPLETED | Nebivolol Ophthalmic Suspension 1 Percent | 5 | |
| Overall Study | NOT COMPLETED | Nebivolol Ophthalmic Suspension 0.5 Percent | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
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 | Instillation site pain | Eye disorders | Nebivolol Ophthalmic Suspension 1 Percent | 1 | 54 | 1 |
| other | Instillation site pain | Eye disorders | Nebivolol Ophthalmic Suspension 0.5 Percent | 0 | 58 | 0 |
| other | Instillation site pain | Eye disorders | Timolol Ophthalmic Suspension 0.5 Percent | 4 | 56 | 4 |
| other | Instillation site pain | Eye disorders | Timolol Ophthalmic Solution 0.5 Percent | 4 | 58 | 4 |
| other | Instillation site reaction | Eye disorders | Nebivolol Ophthalmic Suspension 1 Percent | 4 | 54 | 4 |
| other | Instillation site reaction | Eye disorders | Nebivolol Ophthalmic Suspension 0.5 Percent | 0 | 58 | 0 |
| other | Instillation site reaction | Eye disorders | Timolol Ophthalmic Suspension 0.5 Percent | 1 | 56 | 1 |
| other | Instillation site reaction | Eye disorders | Timolol Ophthalmic Solution 0.5 Percent | 0 | 58 | 0 |
| other | Conjunctival hyperemia | Eye disorders | Nebivolol Ophthalmic Suspension 1 Percent | 0 | 54 | 0 |
| other | Conjunctival hyperemia | Eye disorders | Nebivolol Ophthalmic Suspension 0.5 Percent | 0 | 58 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebivolol Ophthalmic Suspension 1 Percent | 0 | 54 |
| Total, all-cause mortality | Nebivolol Ophthalmic Suspension 0.5 Percent | 0 | 58 |
| Total, all-cause mortality | Timolol Ophthalmic Suspension 0.5 Percent | 0 | 56 |
| Total, all-cause mortality | Timolol Ophthalmic Solution 0.5 Percent | 0 | 58 |
| Total, other adverse events | Nebivolol Ophthalmic Suspension 1 Percent | 7 | 54 |
| Total, other adverse events | Nebivolol Ophthalmic Suspension 0.5 Percent | 6 | 58 |
| Total, other adverse events | Timolol Ophthalmic Suspension 0.5 Percent | 7 | 56 |
| Total, other adverse events | Timolol Ophthalmic Solution 0.5 Percent | 6 | 58 |
| Total, serious adverse events | Nebivolol Ophthalmic Suspension 1 Percent | 0 | 54 |
| Total, serious adverse events | Nebivolol Ophthalmic Suspension 0.5 Percent | 0 | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT04910100
GET https://conductscience.org/api/trials/v1/NCT04910100/results?page=2