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Completed

NCT Number: NCT06461455

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

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr.Elsa Pao, O.D, Oakland, California, United States

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About this study

Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
  • Willing to not use readers while wearing study contact lenses for duration of the study;
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
  • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
  • Monovision contact lens wearers and wearers of contact lens in one eye only;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lehfilcon A multifocal for astigmatism contact lenses

Device

Investigational multifocal contact lenses for astigmatism

Samfilcon A multifocal for astigmatism contact lenses

Device

Commercially available multifocal contact lenses for astigmatism

Other names: ULTRA® Multifocal for Astigmatism

CLEAR CARE® Cleaning & Disinfecting Solution

Device

Hydrogen peroxide-based contact lens cleaning and disinfection system

Other names: CLEAR CARE

Primary outcomes

  1. Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses

    Time frame: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.

    Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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