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OpenTrials
Completed

NCT Number: NCT03392532

Comparison of Two Silicone Hydrogel Toric Contact Lenses

The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
  • Astigmatism
  • Requires contact lenses
  • Best corrected visual acuity of 20/25 or better in each eye
  • Other protocol-specified inclusion criteria may apply

Exclusion criteria

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator
  • Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
  • Other protocol-specified exclusion criteria may apply

Treatment and study plan

Lotrafilcon B toric contact lenses with HYDRAGLYDE

Device

Silicone hydrogel soft contact lenses for astigmatism

Other names: AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses, AOHG for Astigmatism

Lotrafilcon B toric contact lenses

Device

Silicone hydrogel soft contact lenses for astigmatism

Other names: AIR OPTIX® for Astigmatism contact lenses, AO for Astigmatism

Primary outcomes

  1. Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)

    Time frame: Day 1, 10 minutes after lens insertion, each product

    Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2018
Registry last updated
Jan 29, 2019

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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