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. 2022 Oct 21;2022(10):CD015070. doi: 10.1002/14651858.CD015070.pub2

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)
Participants Country: USA
Setting: multicenter
Interventions: 
  • KPI‐121 (loteprednol etabonate 0.25%)


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
  • Vehicle of KPI‐121


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
  • Overall


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)
Interventions  
  • KPI‐121 (loteprednol etabonate 0.25%), 4 times a day for 14 days

  • Vehicle for KPI‐121, 4 times a day for 14 days


 
Outcomes Time points of primary outcome data collected: baseline/visit 2 (day 1) and visit 4 (day 15)
Primary outcomes of the study
  1. Change from baseline/visit 2 (day 1) in bulbar conjunctival hyperemia at visit 4 (day 15) 

  2. Change from baseline/visit 2 (day 1) in ocular discomfort severity at visit 4 (day 15)


Other outcomes of the study
  1. Proportion of participants with ≥ 1 unit improvement from baseline/visit 2 (day 1) in bulbar conjunctival hyperemia worst region at visit 4 (day 15) 

  2. Change from baseline/visit 2 (day 1) in ocular discomfort severity scores at visit 3 (day 8) 

  3. Change from baseline/week 2 (day 1) in ocular discomfort scores to day 4 

  4. Change from baseline/week 2 (day 1) in ocular discomfort severity at visit 4 (day 15) in a subgroup 

  5. Change from baseline/visit 2 (day 1) in ocular discomfort severity scores at day 3 (diary) 

  6. Change from baseline/visit 2 (day 1) in eye dryness scores at visit 4 (day 15) 

  7. Change from baseline/visit 2 (day 1) in eye dryness scores at visit 3 (day 8) 

  8. Ocular discomfort severity scores on day 2 (diary) minus baseline/visit 2 (day 1) 

  9. Change from baseline/visit 2 (day 1) in ocular discomfort frequency scores at visit 4 (day 15)—change from baseline/visit 2 (day 1) in participant‐rated ocular discomfort frequency scores at visit 3 (day 8) 

  10. Change from baseline/visit 2 (day 1) in inferior corneal fluorescein staining score at visit 4 (day 15) 

  11. Change from baseline/visit 2 (day 1) in nasal corneal fluorescein staining score at visit 4 (day 15)

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:
  1. Trial registration no.: NCT02819284 (other study ID KPI‐121‐C‐007)

  2. Trial registration website: ClinicalTrials.gov

  3. Financial disclosure or conflicts of interest statement from authors: NR

Notes  
  • 77% of participants were white.

  • Both treatment‐related and non‐treatment‐related adverse events were reported together.