Trial · NCT03804268
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
NCT03804268, Phase 3, Completed, Allergan; results first posted 2021-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia. Trials, record NCT03804268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03804268
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
- NCT number
- NCT03804268
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Presbyopia
- Interventions
- Vehicle, Pilocarpine HCl Ophthalmic Solution
- First posted
- 2019-01-15
- Last updated
- 2021-12-28
- Results first posted
- 2021-12-28
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | Visual acuity for near (40 centimeters (cm)) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter (cd/m\^2) measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported. |
| Secondary | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6 | Baseline (Day 1) to Day 30 (Hour 6) | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported. |
| Secondary | Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 | Baseline (Day 1) to Day 30 (Hour 8) | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 candelas per square meter measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast DCNVA are reported. |
| Secondary | Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 | Baseline (Day 1) to Day 30 (Hour 0.5) | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. Mixed effect model for repeated measures (MMRM) was used for analyses. |
| Secondary | Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1 | Day 30 (Hour 1) | Visual acuity for near (40 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported. |
| Secondary | Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | NVPTQ had 12 questions on 4 reading tasks(reading a paragraph from book, excerpts from an article in newspaper, portion of a nutrition label, and a section from restaurant menu). Participants completed specific reading tasks under mesopic conditions without any near-vision correction and answered 3 questions for each task, rating their vision-related reading ability as 0=I could not read any text due to problems seeing up close,1=poor,2=fair,3=good,4=very good,5=excellent;impact of squinting on performance as 0=No,I did not squint, 1=Yes,squinting helped me read some/all text, 2=Yes,but I still could not read any of the text; and satisfaction as 0=very dissatisfied to 4=very satisfied. The score based on vision related ability and impact of squinting=(Book testlet+Newspaper testlet+Menu testlet+Nutrition Label testlet)/(testlets with non-missing responses), total possible score of 0-5. Higher scores=better outcomes;positive change from Baseline=improved performance(reading ability). |
| Secondary | Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | Visual acuity for intermediate (66 cm) target was measured in photopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses. |
| Secondary | Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 | Baseline (Day1) to Day 30 (Hour 10) | Visual acuity for near (40cm) target was measured in mesopic conditions using an eye chart. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2measured at the target. Percentage of participants with 3 lines or more improvement from Baseline in mesopic, high-contrast, binocular DCNVA are reported. |
| Secondary | Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25 | Baseline (Day 1) to Day 30 (Hour 0.25) | Visual acuity for near (40 cm) target was measured in mesopic conditions. Mesopic condition was defined as low lighting 3.2 to 3.5 cd/m\^2 measured at the target. A positive change from Baseline indicates improvement in visual acuity. MMRM was used for analyses. |
| Secondary | Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3 | Day 30 (Hour 3) | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Photopic condition was defined as high lighting ≥80 cd/m\^2 measured at the target. Percentage of participants achieving 20/40 or better in photopic, high-contrast, binocular, DCNVA are reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | Intent-to-treat (ITT) Population included all randomized participants. Missing data was imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6 | Baseline (Day 1) to Day 30 (Hour 6) | ITT Population included all randomized participants. Missing data was imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 | Baseline (Day 1) to Day 30 (Hour 8) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 | Baseline (Day 1) to Day 30 (Hour 0.5) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. | letters read correctly | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1 | Day 30 (Hour 1) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. Analysis of Covariance (ANCOVA) was used for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Photopic, High-contrast, Binocular Distance-corrected Intermediate Visual Acuity (DCIVA) Letters at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. | letters read correctly | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 10 | Baseline (Day1) to Day 30 (Hour 10) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.25 | Baseline (Day 1) to Day 30 (Hour 0.25) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. | letters correctly read | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 3 | Day 30 (Hour 3) | ITT Population included all randomized participants. Overall number analyzed is the number of participants with data available for analyses at Baseline and the timepoint. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 | Vehicle | 8.1 | percentage of participants | ||
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 | Pilocarpine HCl Ophthalmic Solution | 30.7 | percentage of participants | ||
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6 | Vehicle | 8.8 | percentage of participants | ||
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 6 | Pilocarpine HCl Ophthalmic Solution | 18.4 | percentage of participants | ||
| Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 | Vehicle | 8.5 | percentage of participants | ||
| Percentage of Participants Gaining 3-lines or More in Mesopic, High-contrast, Binocular, DCNVA at Day 30, Hour 8 | Pilocarpine HCl Ophthalmic Solution | 10.6 | percentage of participants | ||
| Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 | Vehicle | 4.2 | Standard Error 0.55 | letters read correctly | |
| Change From Baseline in Mesopic, High-contrast, Binocular DCNVA Letters at Day 30, Hour 0.5 | Pilocarpine HCl Ophthalmic Solution | 9.3 | Standard Error 0.54 | letters read correctly | |
| Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1 | Vehicle | 73.9 | percentage of participants | ||
| Percentage of Participants Achieving 20/40 or Better in Photopic, High-contrast, Binocular, DCNVA at Day 30, Hour 1 | Pilocarpine HCl Ophthalmic Solution | 92.5 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle | 160 | |
| Overall Study | STARTED | Pilocarpine HCl Ophthalmic Solution | 163 | |
| Overall Study | COMPLETED | Vehicle | 153 | |
| Overall Study | COMPLETED | Pilocarpine HCl Ophthalmic Solution | 161 | |
| Overall Study | NOT COMPLETED | Vehicle | 7 | |
| Overall Study | NOT COMPLETED | Pilocarpine HCl Ophthalmic Solution | 2 |
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 |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Vehicle | 15 | 159 | |
| other | Headache | Nervous system disorders | Pilocarpine HCl Ophthalmic Solution | 23 | 163 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle | 0 | 160 |
| Total, all-cause mortality | Pilocarpine HCl Ophthalmic Solution | 0 | 163 |
| Total, other adverse events | Vehicle | 15 | 159 |
| Total, other adverse events | Pilocarpine HCl Ophthalmic Solution | 23 | 163 |
| Total, serious adverse events | Vehicle | 0 | 159 |
| Total, serious adverse events | Pilocarpine HCl Ophthalmic Solution | 0 | 163 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Pilocarpine HCl Ophthalmic Solution vs Vehicle: deaths from any cause | Trial comparisons |
| Pilocarpine HCl Ophthalmic Solution vs Vehicle: 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/NCT03804268
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