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

Not Applicable
Completed
Conditions
Astigmatism
Presbyopia
Registration Number
NCT06461455
Lead Sponsor
Alcon Research
Brief Summary

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.

Detailed Description

Participants will be expected to attend 5 office visits for an individual duration of participation of approximately 64 days.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
88
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Binocular visual acuity at distance (4 meters) at Day 30 with study lensesDay 30 (-2/+1) of each wear period. A wear period is 30 days (-2/+1) according to randomization assignment.]

High contrast, high illumination visual acuity (VA) will be assessed at a distance of 4 meters for both eyes together with study lenses in place. VA will be measured using letter charts and recorded in logarithm minimum angle of resolution (logMAR), with a logMAR value of 0 equating to 20/20 Snellen VA (normal distance eyesight) and lower logMAR values representing better eyesight.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Dr.Elsa Pao, O.D

🇺🇸

Oakland, California, United States

Pacific Rims Optometry

🇺🇸

San Francisco, California, United States

Drs. Giedd, P.A.

🇺🇸

Maitland, Florida, United States

Vision Health Institute

🇺🇸

Orlando, Florida, United States

Kannarr Eye Care LLC

🇺🇸

Pittsburg, Kansas, United States

Wesley Optometric Consulting

🇺🇸

Medina, Minnesota, United States

Oculus Research, Inc.

🇺🇸

Garner, North Carolina, United States

ProCare Vision Centers, Inc.

🇺🇸

Granville, Ohio, United States

Insight Research Clinic LLC

🇺🇸

Powell, Ohio, United States

Optometry Group, PLLC

🇺🇸

Memphis, Tennessee, United States

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

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