Comparison · NCT03660475-6ce50540
Naltrexone vs Placebo: Number of Participants With Treatment-related Adverse Events
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. Naltrexone vs Placebo: Number of Participants With Treatment-related Adverse Events. Trial comparisons, record NCT03660475-6ce50540. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03660475-6ce50540
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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 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0333 | -0.167 | 0.0834 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Naltrexone than on Placebo | 30 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Naltrexone | Naltrexone Ophthalmic Solution 0.002%~Naltrexone: naltrexone formulated as ophthalmic solution | 0 | 30 | OG000 |
| Group 2 | Placebo | Placebo Ophthalmic Solution~Placebos: Placebo ophthalmic solution | 1 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Treatment-related Adverse Events
- Description
An adverse event is defined as any untoward medical occurrence associated with the use of the investigational agent (or placebo) regardless of whether or not it is considered related to the investigational drug (or placebo).
- Time frame
- Adverse events will be collected from first dose of study drug to 30 days after treatment discontinuation (Day 29 + 4 weeks).
- Population
Source ClinicalTrials.gov
Trial
- Title
- Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects
- NCT number
- NCT03660475
- Phases
- PHASE2
- Conditions
- Dry Eye Disease
- Interventions
- Naltrexone, Placebos
- Lead sponsor
- Sassani, Joseph S., MD, MHA
- Results first posted
- 2022-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03660475?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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