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COMPLETED Phase 3

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

NCT04599972 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04599972

The ClinicalTrials.gov registry entry for NCT04599972 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orasis Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04599972 reports 18 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04599972?

The interventions under investigation include: Vehicle (DRUG), CSF-1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04599972?

This trial is sponsored by Orasis Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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