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NCT02793817 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

A Phase 3 study of Post Surgical Ocular Inflammation and Pain, sponsored by Kala Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
520
Enrollment target
20
Study locations

NCT02793817 is a Phase 3 study of Post Surgical Ocular Inflammation and Pain that has completed, run by Kala Pharmaceuticals. The registered enrollment target is 520 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT02793817, a Phase 3 study of Post Surgical Ocular Inflammation and Pain, has completed, sponsored by Kala Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
520 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG KPI-121 1% Ophthalmic Suspension dosed BID
  • DRUG Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Study Locations (20)

California

  • Sall Research Medical Center - Artesia
  • Orange County Ophthalmology - Garden Grove
  • Lugene Eye Institute - Glendale
  • Inland Eye Specialists - Hemet
  • United Medical Research Institute - Inglewood
  • LoBue Laser and Eye Medical Center - Murrieta
  • Pendleton Eye Center - Oceanside
  • North Bay Eye Associates, Inc. - Petaluma
  • Arch Health Partners - Poway
  • Martel Eye Medical Group - Rancho Cordova
  • Shasta Eye Medical Group, Inc - Redding

Florida

  • Eye Associates of Fort Myers - Fort Myers
  • Levenson Eye Associates - Jacksonville
  • Shettle Eye Research, Inc - Largo
  • International Research Center - Tampa

Arizona

  • Arizona Eye Center - Chandler
  • Cornea and Cataract Consultants of CA - Phoenix

Illinois

  • Chicago Cornea Consultants, Ltd. - Hoffman Estates
  • Jacksoneye, S. C. - Lake Villa

Colorado

  • Eye Center of Northern Colorado, PC - Fort Collins

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2016-06
Est. Completion 2017-03
Phase Phase 3

Sponsor

Kala Pharmaceuticals

9 total trials

What the Registry Record Tells You About NCT02793817

The ClinicalTrials.gov registry entry for NCT02793817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kala Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Post Surgical Ocular Inflammation and Pain appearing as the primary indexed condition, and to 2 interventions - of which KPI-121 1% Ophthalmic Suspension dosed BID is the first listed.

NCT02793817 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02793817 about?

NCT02793817 is a clinical study titled "Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain". 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.

What is the current status of trial NCT02793817?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2016-06. Estimated completion is 2017-03.

What conditions does trial NCT02793817 study?

This clinical trial studies the following conditions: Post Surgical Ocular Inflammation and Pain.

What interventions are being tested in trial NCT02793817?

The interventions under investigation include: KPI-121 1% Ophthalmic Suspension dosed BID (DRUG), Vehicle of KPI-121 Ophthalmic Suspension dosed BID (DRUG).

Who is sponsoring clinical trial NCT02793817?

This trial is sponsored by Kala Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02793817 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.