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NCT05765227 · ClinicalTrials.gov registry record · NA

Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

A NA study of Refractive Ametropia, sponsored by Alcon Research.

Completed
Registry status
NA
Development phase
18
Enrollment target
1
Study location

NCT05765227: Completed NA study of Refractive Ametropia, sponsored by Alcon Research.

NCT05765227 is a NA study of Refractive Ametropia that has completed, run by Alcon Research. The registered enrollment target is 18 participants, below the 231-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05765227, a NA study of Refractive Ametropia, has completed, sponsored by Alcon Research.

COMPLETED
Registry status
NA
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Primary Outcome

VA was assessed binocularly (both eyes together) using a letter chart and measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No hypothesis testing was prespecified for this endpoint.

Conditions Studied

Interventions

  • DEVICE Lehfilcon A multifocal contact lenses
  • DEVICE Lotrafilcon B multifocal contact lenses
  • DEVICE Hydrogen peroxide-based cleaning and disinfection system

Study Locations (1)

Georgia

  • Johns Creek Research Clinic - Johns Creek

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2023-03-08
Est. Completion 2023-03-30
Phase NA
Alcon Research

275 total trials

What the finished NCT05765227 record still lists

NCT05765227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 231-participant average among 5 other Refractive Ametropia trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Refractive Ametropia appearing as the primary indexed condition, and to 3 interventions - of which Lehfilcon A multifocal contact lenses is the first listed.

NCT05765227 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT05765227 about?

NCT05765227 is a clinical study titled "Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens". The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

What is the current status of trial NCT05765227?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2023-03-08. Estimated completion is 2023-03-30.

What conditions does trial NCT05765227 study?

This clinical trial studies the following conditions: Refractive Ametropia.

What interventions are being tested in trial NCT05765227?

The interventions under investigation include: Lehfilcon A multifocal contact lenses (DEVICE), Lotrafilcon B multifocal contact lenses (DEVICE), Hydrogen peroxide-based cleaning and disinfection system (DEVICE).

Who is sponsoring clinical trial NCT05765227?

This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05765227 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05765227, the US trial registry maintained by the National Library of Medicine. NCT05765227 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.