Comparison · NCT04599972-1686f2d2
CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CSF-1 vs Vehicle: Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2. Trial comparisons, record NCT04599972-1686f2d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04599972-1686f2d2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.519 | 0.441 | 0.597 | wilson | |
| Risk in group 2 | 0.167 | 0.116 | 0.234 | wilson | |
| Risk difference, group 1 minus group 2 | 0.353 | 0.249 | 0.446 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.12 | 2.11 | 4.6 | log | |
| Odds ratio, group 1 over group 2 | 5.41 | 3.17 | 9.21 | log | |
| Number needed to treat, for one more participant with the outcome on CSF-1 than on Vehicle | 2.83 | 2.24 | 4.01 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CSF-1 | One drop bilaterally twice daily for approximately 2 weeks.~CSF-1: One drop bilaterally twice daily for approximately 2 weeks. | 80 | 154 | OG000 |
| Group 2 | Vehicle | One drop bilaterally twice daily for approximately 2 weeks.~Vehicle: One drop bilaterally twice daily for approximately 2 weeks. | 25 | 150 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2
- Description
The key secondary endpoints were measured on Day 8 at different time points and were the percentage of subjects with a ≥ 3-line (15-letter) gain, from baseline, in BDCVA at 40 cm (Precision Vision Chart) and no loss in BDCVA ≥ 5 letters (ETDRS chart at 4 m) in the study eye.
- Time frame
- Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1)
- Population
Source ClinicalTrials.gov
Trial
- Title
- An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
- NCT number
- NCT04599972
- Phases
- PHASE3
- Conditions
- Presbyopia
- Interventions
- CSF-1, Vehicle
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Results first posted
- 2023-11-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04599972?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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