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NCT03809611 · ClinicalTrials.gov registry record · Phase 2

A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.

A Phase 2 study of Presbyopia, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
125
Enrollment target
14
Study locations

NCT03809611 is a Phase 2 study of Presbyopia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 125 participants, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (53% lower). The trial reports 14 study locations across 7 states.

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The verdict

NCT03809611, a Phase 2 study of Presbyopia, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
125 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

Conditions Studied

Presbyopia

Interventions

  • DRUG Placebo
  • DRUG UNR844-Cl

Study Locations (14)

Pennsylvania

  • Novartis Investigative Site - Allenwood
  • Novartis Investigative Site - Cranberry Township
  • Novartis Investigative Site - Kingston

Tennessee

  • Novartis Investigative Site - Memphis
  • Novartis Investigative Site - Nashville
  • Novartis Investigative Site - Nashville

California

  • Novartis Investigative Site - Mission Hills
  • Novartis Investigative Site - Newport Beach

Florida

  • Novartis Investigative Site - Largo
  • Novartis Investigative Site - Mt. Dora

Texas

  • Novartis Investigative Site - Cedar Park
  • Novartis Investigative Site - Houston

Missouri

  • Novartis Investigative Site - Washington

Virginia

  • Novartis Investigative Site - Norfolk

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2019-04-26
Est. Completion 2019-12-16
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT03809611

The ClinicalTrials.gov registry entry for NCT03809611 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 267-participant average among 38 other Presbyopia trials with a reported enrollment target (53% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03809611 reports 14 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Tennessee, California.

Frequently Asked Questions

What is clinical trial NCT03809611 about?

NCT03809611 is a clinical study titled "A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.". The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

What is the current status of trial NCT03809611?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2019-04-26. Estimated completion is 2019-12-16.

What conditions does trial NCT03809611 study?

This clinical trial studies the following conditions: Presbyopia.

What interventions are being tested in trial NCT03809611?

The interventions under investigation include: Placebo (DRUG), UNR844-Cl (DRUG).

Who is sponsoring clinical trial NCT03809611?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03809611 being conducted?

This trial has 14 study locations across California, Florida, Missouri, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.