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

KPI‐121 (STRIDE1).

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): 2017/10 (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)
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: descriptions about power and sample size calculation were partially blocked in the publicly available trial protocol
Participants Country: USA
Setting: multicenter
Interventions:

  • KPI‐121 (loteprednol etabonate 0.25%)


Age, mean/SD (range): 58.1/15.4
Female, n (%): 367 (80.0%)
Etiology, n (%): NR
Participants (eyes) randomized: 459
Participants (eyes) analyzed for primary study outcomes: 452/455
Participants (eyes) analyzed for safety outcomes: 459

  • Vehicle of KPI‐121


Age, mean/SD (range): 58.3/14.7
Female, n (%): 359 (78.7%)
Etiology, n (%): NR
Participants (eyes) randomized: 456
Participants (eyes) analyzed for primary study outcomes: 451/452
Participants (eyes) analyzed for safety outcomes: 456

  • Overall


Age, mean/SD (range): 58.2/15.0
Female, n (%): 726 (79.3%)
Etiology, n (%): NR
Participants (eyes) randomized: 915
Participants (eyes) analyzed for primary study outcomes: 903/907
Participants (eyes) analyzed for safety outcomes: 915
Inclusion criteria: 

  1. 18 years of age or older 

  2. Have a documented clinical diagnosis of dry eye disease in both eyes 

  3. Have ongoing dry eye disease as defined by the following criteria in the same eye or both eyes: 

    1. a corneal fluorescein staining score at Visit 1 and Visit 2 of [blocked]* (National Eye Institute [NEI] scale); and

    2. bulbar conjunctival hyperemia at Visit 1 and Visit 2 of [blocked] as assessed using the Cornea and Contact Lens Research Unit (CCLRU) scale; and

    3. a score of [blocked] Severity Assessment at Visit 1 and a score of [blocked] Severity Visit 2 (Day 1); and 

    4. an unanesthetized Schirmer test score at Visit 1 of [blocked]. (more criteria shown in the study protocol)


*[blocked] were phrases or words in the study protocol that were blocked from viewing
Exclusion criteria: 

  1. Have a known hypersensitivity or contraindication to the investigational product(s) or their components

  2. Have used any of the following medications within 30 days prior to Screening (Visit 1) or for the duration of the study:

    1. ocular, inhaled, or intranasal corticosteroids;

    2. ocular or oral non‐steroidal anti‐inflammatory drugs (NSAIDs), with the exception of ≤ 81 mg/day of acetylsalicylic acid (ASA or aspirin);

    3. topical ocular antibiotics;

    4. topical ocular antihistamines or mast cell stabilizers;

    5. oral antihistamines;

    6. topical or nasal vasoconstrictors.

  3. Have used any of the following medications within 60 days prior to Screening (Visit 1) or for the duration of the study: topical ciclosporin (Restasis), topical lifitegrast, any form of topical loteprednol etabonate 

  4. Have altered oral dosing of the following within 30 days prior to Screening (Visit 1) or anticipate alteration of dosing during the study: 

    1. tetracycline compounds (e.g. tetracycline, doxycycline, or minocycline);

    2. Omega‐3 or Omega‐6 supplements. 

  5. Have altered dosing of the following medications within 6 months prior to Screening (Visit 1) or anticipate alteration of dosing during the study: 

    1. anticholinergics;

    2. anticonvulsants (e.g. topiramate);

    3. antidepressants;

    4. isotretinoin;

    5. systemic immunosuppressive agents including oral corticosteroids at a dose of prednisone < 11 mg/day or equivalent. 


NOTE: oral corticosteroid use at a dose of prednisone > 11 mg/day or equivalent is excluded. (more criteria shown in the study protocol)
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: change from Visit 2 (Day 1) to 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) 

  3. Change from baseline/Visit 2 (Day 1) in corneal fluorescein staining score at Visit 4 (Day 15) 

  4. Change from baseline/Visit 2 (Day 1) ocular discomfort severity at Visit 4 (Day 15) in the subgroup of participants with more severe ocular discomfort


Other outcomes of the study: 

  1. Change in conjunctival hyperemia scores at Visit 4 (Day 15) in the subgroup of participants with more severe ocular discomfort at baseline (Day 1) 

  2. Proportion of participants with ≥1 improvement in conjunctival hyperemia at Visit 4 (Day 15) 

  3. Change from baseline/Visit 2 (Day 1) conjunctival hyperemia scores at Visit 4 (Day 15) for the mean of all regions (nasal, temporal, frontal) 

  4. Change in ocular discomfort severity scores prior to Visit 3 (Day 8) minus the mean of the scores to baseline/Visit 2 (Day 1) 

  5. Change in ocular discomfort severity scores prior to Visit 3 (Day 8) minus baseline/Visit 2 (Day 1) in the subgroup of participants with more severe ocular discomfort 

  6. Change in ocular discomfort severity scores on Day 4 (Diary) minus baseline/Visit 2 (Day 1) 

  7. Change in ocular discomfort severity scores on Day 4 (Diary) minus baseline/Visit 2 (Day 1) in the subgroup of participants with more severe ocular discomfort 

  8. Change from baseline/Visit 2 (Day 1) in conjunctival hyperemia scores with a Day 1 conjunctival hyperemia score of ≥ 2 in the subgroup of participants with more severe ocular discomfort

  9. Participants with a grade of 0 in conjunctival hyperemia 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.: NCT02813265 (other study ID: KPI‐121‐C‐006)

  2. Trial registration website: ClinicalTrials.gov

  3. Financial disclosure or conflicts of interest statement from authors: NR
Notes 79% of participants were white.