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

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No

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
Kala Pharmaceuticals

9 total trials

What the finished NCT02793817 record still lists

NCT02793817 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).

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 names 20 study sites across 5 states, led by 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.

How this trial's enrollment target compares

Where NCT02793817's enrollment target sits among peer trials

520 717th of 2000 higher than 1,278 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02793817, the US trial registry maintained by the National Library of Medicine. NCT02793817 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.