18 and older, any sex, with Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Corneal Fluorescein StainingPrimary· 1 month
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
Group
Value
95% CI
Treatment Arm
0.5
± 0.7
Control Arm
3
± 0
Eye Dryness ScoreSecondary· 1 month
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Group
Value
95% CI
Treatment Arm
57.5
± 46
Control Arm
75
± 0
Ocular Surface Disease Index (OSDI)Secondary· 1 month
Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability
Group
Value
95% CI
Treatment Arm
64.5
± 35
Control Arm
52
± 0
Sponsor's own description
A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by BioTissue Holdings, Inc
Last refreshed: 23 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04015219.