Trial · NCT03804268
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | Mean Change From Baseline in Mesopic NVPTQ Satisfaction 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. ANCOVA was used for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Presbyopia Impact and Coping Questionnaire (PICQ) Coping 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. ANCOVA was used for analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in PICQ Impact 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. ANCOVA was used for analysis. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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