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NCT04599972 · ClinicalTrials.gov registry record · Phase 3

An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)

A Phase 3 study of Presbyopia, sponsored by Orasis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
304
Enrollment target
18
Study locations

NCT04599972 is a Phase 3 study of Presbyopia that has completed, run by Orasis Pharmaceuticals. The registered enrollment target is 304 participants, above the 263-participant average among 38 other Presbyopia trials with a reported enrollment target (16% higher). The trial reports 18 study locations across 11 states.

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The verdict

NCT04599972, a Phase 3 study of Presbyopia, has completed, sponsored by Orasis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
304 participants
Enrollment target
18
Study locations

Study Summary

This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

Conditions Studied

Interventions

  • DRUG Vehicle
  • DRUG CSF-1

Study Locations (18)

California

  • Orasis Investigative Site - Garden Grove
  • Orasis Investigative Site - Mission Hills
  • Orasis Investigative Site - Newport Beach
  • Orasis Investigative Site - Petaluma

Arizona

  • Orasis Investigative Site - Chandler
  • Orasis Investigative Site - Mesa
  • Orasis Investigative Site - Phoenix

Texas

  • Orasis Investigative Site - Cedar Park
  • Orasis Investigative Site - San Antonio

Utah

  • Orasis Investigative Site - Clinton
  • Orasis Investigative Site - Draper

Colorado

  • Orasis Investigative Site - Littleton

Connecticut

  • Orasis Investigative Site - Danbury

Florida

  • Orasis Investigative Site - Delray Beach

Illinois

  • Orasis Investigative Site - Rock Island

Trial Details

FieldValue
Enrollment Target 304 participants
Start Date 2020-10-26
Est. Completion 2022-01-28
Phase Phase 3

Sponsor

Orasis Pharmaceuticals

4 total trials

What the Registry Record Tells You About NCT04599972

The ClinicalTrials.gov registry entry for NCT04599972 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 263-participant average among 38 other Presbyopia trials with a reported enrollment target (16% higher). The listed sponsor is Orasis Pharmaceuticals, which has 4 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 Vehicle is the first listed.

NCT04599972 reports 18 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Texas.

Frequently Asked Questions

What is clinical trial NCT04599972 about?

NCT04599972 is a clinical study titled "An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)". This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.

What is the current status of trial NCT04599972?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2020-10-26. Estimated completion is 2022-01-28.

What conditions does trial NCT04599972 study?

This clinical trial studies the following conditions: Presbyopia.

What interventions are being tested in trial NCT04599972?

The interventions under investigation include: Vehicle (DRUG), CSF-1 (DRUG).

Who is sponsoring clinical trial NCT04599972?

This trial is sponsored by Orasis Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04599972 being conducted?

This trial has 18 study locations across Arizona, California, Colorado, Connecticut, Florida. 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.