Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)

K

Kala Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Dry Eye Syndromes
Keratoconjunctivitis Sicca

Treatments

Drug: KPI-121 0.25% Ophthalmic Suspension
Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT02819284
KPI-121-C-007

Details and patient eligibility

About

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).

Full description

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Enrollment

909 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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, 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

909 participants in 2 patient groups, including a placebo group

KPI-121 0.25% Ophthalmic Suspension
Active Comparator group
Treatment:
Drug: KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Placebo Comparator group
Treatment:
Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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