KPI‐121 (STRIDE2).
Study characteristics | ||
Methods |
00. Study design: randomized controlled trial, parallel group 01. Calendar time when the study enrolled the first participant (YYYY/MM): 2016/06 (ClinicalTrials.gov) 02. Calendar time when the study completed follow‐up (YYYY/MM): 2017/09 (ClinicalTrials.gov) 03. Unit of randomization (participant or eye): participant 04. Masking of participants, treatment allocator, outcome assessor, or data analyzer: quadruple (participant, care provider, investigator, outcomes assessor) 05. Study visits and the corresponding time points: Visit 1 (14 ± 1 days before Visit 2) for screening Visit 2 (Day 1) for randomization Visit 3 (Day 8 ± 1) Visit 4 (Day 15 ± 1) 06. Instruments and the scales used for documenting patient‐reported symptoms or quality of life: participant‐rated assessment of ocular discomfort [blocked]* utilizing [blocked] VAS (0 to 100). *[blocked] were phrases or words in the study protocol that were blocked from viewing 07. Assessment for safety outcomes: adverse events; slit lamp biomicroscopy; IOP measurement; BCVA 08. Planned follow‐up duration: 15 days 09. Actual follow‐up duration: 15 days 10. Planned treatment duration (of the intervention steroid): 14 days 11. How missing data were handled: complete‐case analysis 12. Description on power and sample size calculation: (same as in the study protocol for STRIDE 1) |
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Participants |
Country: USA Setting: multicenter Interventions:
Age, mean/SD (range): 59.1/14.5 Female, n (%): 332 (73.5%) Etiology, n (%): NR Participants (eyes) randomized: 452 Participants (eyes) analyzed for primary study outcomes: 445/446 Participants (eyes) analyzed for safety outcomes: 452
Age, mean/SD (range): 59.3/15.0 Female, n (%): 354 (78.1%) Etiology, n (%): NR Participants (eyes) randomized: 453 Participants (eyes) analyzed for primary study outcomes: 444/447 Participants (eyes) analyzed for safety outcomes: 453
Age, mean/SD (range): 59.2/14.7 Female, n (%): 686 (75.8%) Etiology, n (%): NR Participants (eyes) randomized: 905 Participants (eyes) analyzed for primary study outcomes: 889/893 Participants (eyes) analyzed for safety outcomes: 905 Inclusion criteria: (same study protocol for STRIDE 1) Exclusion criteria: (same study protocol for STRIDE 1) Baseline comparison: no significant differences in baseline characteristics between groups (source: ClinicalTrials.gov) |
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Interventions |
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Outcomes |
Time points of primary outcome data collected: baseline/visit 2 (day 1) and visit 4 (day 15) Primary outcomes of the study:
Other outcomes of the study:
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Study Identification |
Sponsorship source: Kala Pharmaceuticals Inc Ethics approval: the study protocol states that: "This protocol and the informed consent form must be approved by an appropriately constituted and qualified IRB and the approvals made available to the sponsor or designee prior to the start of enrollment into the study based on these items" Correspondence author's name: NR Additional information:
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Notes |
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