Trial · NCT06453694
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment Rate | 2 years | Number of enrolled participants per month |
| Primary | Study Adherence Rate | 2 years | Proportion of randomized participants who receive both doses of assigned study intervention, attend all assigned study visits, and complete at least the high contrast visual acuity, low contrast visual acuity, and Pelli-Robson assessments at all visits |
| Primary | Change in high contrast visual acuity for effect size and standard deviation estimation | 1 month | Difference in change in high-contrast visual acuity from baseline to 1 month between groups |
| Primary | Change in low contrast visual acuity for effect size and standard deviation estimation | 1 month | Difference in change in low contrast visual acuity (LCVA) (# of letters seen at 2.5% illumination) from baseline to 1 month between groups |
| Secondary | Retention rate | 2 years | Percentage of enrolled subjects who remain in the study and do not voluntarily withdraw |
| Secondary | Screen failure rate | 2 years | Percentage of participants who fail screening |
| Secondary | Pre-screen failure rate | 2 years | Percentage of participants who fail pre-screening |
| Secondary | Drug adherence rate | 2 years | Percentage of randomized participants who receive 2 full doses of their assigned study intervention |
| Secondary | Full improvement in visual acuity (high contrast) | 30 days | Proportion of participants with full improvement in high contrast visual acuity |
| Secondary | Full improvement in visual acuity (low contrast) | 30 days | Proportion of participants with full improvement in low contrast visual acuity |
| Secondary | Personal maximal improvement (high contrast) | 30 days | Proportion of participants with personal maximal improvement in high contrast visual acuity (defined as individual final visual acuity at 6 months) |
| Secondary | Personal maximal improvement (low contrast) | 30 days | Proportion of participants with personal maximal improvement in high contrast visual acuity (defined as individual final visual acuity at 6 months) |
| Secondary | Improvement in high contrast visual acuity at 3 months | 3 months | Difference in change in high contrast visual acuity from baseline to 3 months between groups |
| Secondary | Improvement in high contrast visual acuity at 6 months | 6 months | Difference in change in high contrast visual acuity from baseline to 6 months between groups |
| Secondary | Rescue treatment | Day 7 | Number and proportion of patients in each arm requiring rescue treatment |
| Secondary | Difference in change in low contrast visual acuity from baseline to 6 months between groups | 3 months | Difference in change in low contrast visual acuity (# of letters seen at 2.5% illumination) from baseline to 3 months between groups |
| Secondary | Difference in change in low contrast visual acuity from baseline to 6 months between groups | 6 months | Difference in change in low contrast visual acuity (# of letters seen at 2.5% illumination) from baseline to 6 months between groups |
| Secondary | The number and proportion of participants with low contrast visual acuity of 0 | 30 days | The number and proportion of participants with low contrast visual acuity of 0 |
| Secondary | Contrast sensitivity | 6 months | Difference in change in Pelli-Robson contrast sensitivity score (# of letters seen at 2.5% illumination) from baseline to each assessment time point between groups |
| Secondary | Color Vision | 6 months | Difference in change in Hardy-Rand-Rittler color vision score from baseline to each assessment time point between groups. Scores range from 0 (lowest) to 6 (highest). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06453694/registered