CompletedPhase 3

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

United States918 participantsStarted 2016-06

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

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

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Trial details

NCT IDNCT02813265

SponsorKala Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2020-09-21

View on ClinicalTrials.gov More Dry Eye Syndromes trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

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

Timeframe: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)