Trial · NCT03203850
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 | Proportion of Patients Achieving Target SF ≤ 100 μg/L for the First Time | Up to Month 24 | The Full Analysis Set (FAS) comprised all subjects to whom study treatment had been assigned by randomization. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Ocular Treatment Emergent Adverse Events (AEs) | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 108 weeks. | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Ocular Treatment Emergent Adverse Events (AEs) by Preferred Term | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 108 weeks. | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 108 weeks. | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Adverse Events in Participants Who Had Study Treatment Interrupted Due to SF ≤ 100 μg/L and Re-initiated Study Treatment When ≥ 300 μg/L | Up to 24 months | Participants in the Safety Set who had study treatment interrupted due to SF ≤ 100 μg/L and re-initiated study treatment when ≥ 300 μg/L. There were no patients who re-initiated therapy when reached SF 300 μg/L. | ||
| SECONDARY | Categorical Analysis of logMAR Score Changes From Baseline to Best Post-baseline Changes in One Eye With More Extreme Change | Baseline, Weeks 24, 52, 76 and 104. | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Categorical Analysis of logMAR Score Changes From Baseline to Worst Post-baseline Changes in One Eye With More Extreme Change | Baseline, Weeks 24, 52, 76 and 104. | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Categorical Analysis of Worst Post-baseline Values of Intraocular Pressure in One Eye With More Extreme Change | Weeks 24, 52, 76 and 104 | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Categorical Analysis of Changes in Intraocular Pressure From Baseline to Best/Worst Post-baseline Changes in One Eye With More Extreme Change | Baseline, up to Week 104 | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Slit Lamp Results for Any Evaluation and Worst Eye | Baseline, up to Week 104 | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Increase From Baseline of ≥1 and ≥2 in LOCS III Grades | Baseline, up to Week 104 | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Fundus Oculi Results for Any Evaluation and Worst Eye | Baseline, up to Week 104 | The Safety Set (SS) included all subjects who received at least one administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | Up to Month 24 | The Full Analysis Set (FAS) comprised all subjects to whom study treatment has been assigned by randomization. | months | MEDIAN |
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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GET https://conductscience.org/api/trials/v1/NCT03203850/outcomes