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Trial record 1 of 1 for:    KPI-121-C-011
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Safety and Efficacy of KPI-121 in Subjects With DED (STRIDE 3)

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ClinicalTrials.gov Identifier: NCT03616899
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Kerato Conjunctivitis Sicca Drug: KPI-121 Ophthalmic Suspension Drug: Vehicle Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension Drug: KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension

Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension Drug: Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension




Primary Outcome Measures :
  1. Ocular Discomfort [ Time Frame: 2 weeks ]
    Patient-reported ocular discomfort'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616899


Contacts
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Contact: Mary Bearkland 781-996-5252 CT006@kalarx.com

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Sponsors and Collaborators
Kala Pharmaceuticals, Inc.

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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03616899     History of Changes
Other Study ID Numbers: KPI-121-C-011
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases