Status:

COMPLETED

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Lead Sponsor:

Alcon Research

Conditions:

Presbyopia

Eligibility:

All Genders

40+ years

Phase:

NA

Brief Summary

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) afte...

Detailed Description

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total ...

Eligibility Criteria

Inclusion

  • Key
  • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
  • Willing and able to attend all study visits as required by the protocol.
  • Willing to stop wearing habitual contact lenses for the duration of the study.
  • Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
  • Other protocol-specified inclusion criteria may apply.
  • Key

Exclusion

  • Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
  • History of refractive surgery or planning to have refractive surgery during the study.
  • Current or history of pathologically dry eye.
  • Currently pregnant or lactating.
  • Other protocol-specified exclusion criteria may apply.

Key Trial Info

Start Date :

May 27 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2022

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT05338333

Start Date

May 27 2022

End Date

September 1 2022

Last Update

September 13 2023

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Kindred Optics at Maitland Vision

Maitland, Florida, United States, 32751

2

Vision Health Institute

Orlando, Florida, United States, 32803

3

Kannarr Eye Care LLC

Pittsburg, Kansas, United States, 66762

4

The Eye Doctors, Inc.

Eden Prairie, Minnesota, United States, 55344

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses | DecenTrialz