Trial · NCT06542497
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8) | 8 Days | The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8). |
| Secondary | Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6 | 6 Weeks | This secondary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Day 1 (1-hour post-dose), Day 3, and Week 6. |
| Secondary | Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | The percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular and Binocular) at Day 1 (0.5 hours and 1 hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in DCNVA from baseline (monocular - study eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the change in DCNVA from baseline (binocular) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6 |
| Secondary | Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS | 6 Weeks | This outcome measure investigates the change in mean binocular DCNVA from baseline at Week 6 compared to the best prior observed change from baseline in mean binocular DCNVA in subjects treated with POS. |
| Secondary | Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 with a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with ≥ 5, ≥ 10, and ≥ 15 letters of improvement in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the change in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the percentage of subjects with loss or improvement in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the change in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure will investigate the Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6. |
| Secondary | Change in Pupil Diameter From Baseline at Day 3 and Day 8 | 8 Days | This outcome measure will investigate the change in pupil diameter from baseline at Day 3 and Day 8. |
| Secondary | Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8 | 8 Days | This outcome measure will investigate the Percent Change in Pupil Diameter from Baseline at Day 3 \& Day 8. |
| Secondary | Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8 | 8 Days | This outcome measure will investigate the percentage of subjects with pupil diameter of \< 3.5, \< 3.0, \< 2.5, \< 2.0, and \< 1.5 mm at Day 3 and Day 8. |
| Secondary | Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8 | 8 Days | This outcome measure will investigate the percentage of subjects with pupil diameter of 1.5 to \< 2.0 mm, 2.0 to \< 2.5 mm, 2.5 to \< 3.0 mm, and 3.0 to \< 3.5 mm at Day 3 and Day 8. |
| Secondary | Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6 | 6 Weeks | This outcome measure investigates the change from baseline in overall and component subject-reported outcomes at Day 3, Day 8, and Week 6. : Responses to each question used a 1-5 scale with 1=Worst outcome and 5=Best outcome. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06542497/registered