Trial · NCT06903884
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Cornea Fluorescein Staining (CFS) score from baseline to 4 weeks, 8 weeks and 16 weeks between study groups | From baseline to 4 months post- treatment between study groups | Higher values mean inferior outcomes. Graded according to the modified Oxford grading scale (range 0, 0.5, 1, 2, 3, 4, 5). A difference in score of at least 2 levels (i.e. 4 to 2) or complete resolution of staining (i.e. 0) are both considered clinically significant endpoints. |
| Secondary | Percentage of patients requiring rescue topical steroid therapy at 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | Number of patients requiring rescue topical steroid therapy divided by all patients participated in this study |
| Secondary | Percentage of patients with improvement in Cornea Fluorescein Staining (CSF) at 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | Number of patients with improvement in CFS requiring rescue topical steroid therapy divided by all patients participated in this study |
| Secondary | Change in best corrected visual acuity from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | From logmar(1.0 to -0.1) |
| Secondary | Change in Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) score from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | Range from 0-28, one mark was collected per patient, with higher scores meaning worse |
| Secondary | Change in Quality of Life in Children with Vernal Keratoconjunctivitis (QUICK) score from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | Range from 0-48, one mark was collected per patient, with higher scores meaning worse outcomes |
| Secondary | Change in NIKBUT from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | NIKBUT is measured in seconds and average of 3 consecutive readings is taken. Higher values mean better outcomes. |
| Secondary | Change in tear meniscus height from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | In millimetres. Readings serve as objective parameters for tear volume |
| Secondary | Change in tear cytokines from baseline to 4 weeks, 8 weeks and 16 weeks | From baseline to 4 months post- treatment between study groups | Percentage change in tear cytokines analysis done in lab |
| Other | Incidence of ocular adverse events | From baseline to 4 months post- treatment between study groups | Number of patients with ocular adverse events divided by all patients participated in this study |
| Other | Incidence of non-ocular adverse events | From baseline to 4 months post- treatment between study groups | Number of patients with non-ocular adverse events divided by all patients participated in this study |
| Other | • Incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life year (QALYs) gained. | From baseline to 4 months post- treatment between study groups | It is defined by the difference in cost between two possible interventions, divided by the difference in their effect. |
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/NCT06903884/registered