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OpenTrials
Completed

NCT Number: NCT05959200

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

The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

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Key information

Conditions

Ametropia Astigmatism Eye Diseases Hyperopia Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Elsa Pao, OD, Oakland, California, United States

Loading trial locations.

About this study

Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes.
  • Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Wearing 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.
  • Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
  • Other exclusion criteria may apply.

Treatment and study plan

Serafilcon A toric contact lenses

Device

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Other names: LID226397

Senofilcon A toric contact lenses

Device

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Other names: ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHP

CLEAR CARE

Device

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Other names: CLEAR CARE® Cleaning and Disinfecting Solution

Primary outcomes

  1. Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion

    Time frame: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.

    The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]). No hypothesis testing was prespecified for this endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2023
Registry last updated
Nov 29, 2024

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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