Phase 3 N=915 Randomized Quadruple-blind Treatment

Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

Dry Eye Syndromes · Keratoconjunctivitis Sicca

Bottom Line

View on ClinicalTrials.gov: NCT02813265 ↗

Enrolled (actual)

915

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) — -0.4049; -0.1574 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: KPI-121 0.25% Ophthalmic Suspension (Drug); Vehicle of KPI-121 0.25% Ophthalmic Suspension (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kala Pharmaceuticals, Inc.
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)	-0.4049; -0.1574	—
PRIMARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)	-14.53; -9.16	—
PRIMARY Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)	-0.5; -0.4	—
PRIMARY 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	-16.67; -10.76	—
SECONDARY Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)	-0.4648; -0.2045	—
SECONDARY Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)	189; 98	—
SECONDARY Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)	-0.2980; -0.0421	—
SECONDARY Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)	-8.12; -4.81	—
SECONDARY 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.	-9.90; -6.38	—
SECONDARY Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)	-6.60; -3.20	—
SECONDARY Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort	-8.48; -5.20	—
SECONDARY 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	-0.47; -0.22	—
SECONDARY Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)	27; 16	—

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 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Known hypersensitivity or contraindication to the investigational product(s) or components
History of glaucoma, Intraocular Pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02813265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.