Comparison of Two Silicone Hydrogel Toric Contact Lenses

Axis Orientation 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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AOHG toric, then AO toric; Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.	Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Silicone hydrogel soft contact lenses for astigmatism; Other Names: AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses; AOHG for Astigmatism; Device: Lotrafilcon B toric contact lenses; Silicone hydrogel soft contact lenses for astigmatism; Other Names: AIR OPTIX® for Astigmatism contact lenses; AO for Astigmatism
Other: AO toric, then AOHG toric; Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.	Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Silicone hydrogel soft contact lenses for astigmatism; Other Names: AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses; AOHG for Astigmatism; Device: Lotrafilcon B toric contact lenses; Silicone hydrogel soft contact lenses for astigmatism; Other Names: AIR OPTIX® for Astigmatism contact lenses; AO for Astigmatism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)	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.	Day 1, 10 minutes after lens insertion, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Astigmatism; Axis orientation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CLC127-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes