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Trial record 1 of 1 for:    A phase 3, double-masked, randomized, controlled study to evaluate the safety and efficacy of KPI-121 1.0% ophthalmic suspension in subjects with post-surgical inflammation and pain
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Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02793817
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

Condition or disease Intervention/treatment Phase
Post Surgical Ocular Inflammation and Pain Drug: KPI-121 1% Ophthalmic Suspension dosed BID Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID Phase 3

Detailed Description:
This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 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 to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
Study Start Date : June 2016
Primary Completion Date : April 2017
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: KPI-121 1.0% Ophthalmic Suspension
dosed BID
Drug: KPI-121 1% Ophthalmic Suspension dosed BID
Other Name: Loteprednol etabonate
Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Other Name: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Proportion of study eyes with complete resolution of anterior chamber cells (cell score = 0) in the study eye [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15) ]
  2. Proportion of study eyes with complete resolution of ocular pain (grade = 0) in the study eye [ Time Frame: Visit 5 (Day 8) maintained through Visit 6 (Day 15)] ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

Candidates for routine, uncomplicated cataract surgery

In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria:

  • Known hypersensitivity/contraindication to study 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; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
  • In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Contacts and Locations

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): NCT02793817


  Show 35 Study Locations
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
More Information

Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02793817     History of Changes
Other Study ID Numbers: KPI-121-C-005
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kala Pharmaceuticals, Inc.:
postsurgical
postoperative
ocular
cataract
inflammation
pain
corticosteroid

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Loteprednol Etabonate
Anti-Allergic Agents