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KPI-121 0.25% Ophthalmic Suspension for Dry Eye Syndrome (Kauai Trial)

Phase 2
Waitlist Available
Led By Gregg Berdy, MD
Research Sponsored by Kala Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Have a documented clinical diagnosis of dry eye disease in both eyes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 4 (day 15) and visit 6 (day 29)
Awards & highlights

Kauai Trial Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Eligible Conditions
  • Dry Eye Syndrome

Kauai Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Kauai Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 4 (day 15) and visit 6 (day 29)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 4 (day 15) and visit 6 (day 29) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bulbar Conjunctival Hyperemia
Secondary outcome measures
Bulbar Conjunctival Hyperemia Scores
Corneal Fluorescein Staining Scores
Ocular Discomfort

Kauai Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: KPI-121 0.25% Ophthalmic SuspensionActive Control1 Intervention
KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease
Group II: VehiclePlacebo Group1 Intervention
Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease

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Who is running the clinical trial?

Kala Pharmaceuticals, Inc.Lead Sponsor
10 Previous Clinical Trials
3,925 Total Patients Enrolled
Gregg Berdy, MDPrincipal InvestigatorOphthalmology Associates
2 Previous Clinical Trials
3,513 Total Patients Enrolled
David Evans, ODPrincipal InvestigatorTotal Eye Care, PA
~14 spots leftby Jun 2025
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