Comparison of Two Silicone Hydrogel Toric Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE; Device: Lotrafilcon B toric contact lenses

• Registration Number: NCT03392532
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-02
• Study Start: 2018-01-04
• Study First Posted: 2018-01-08
• Primary Completion: 2018-01-26
• Study Completion: 2018-01-26
• Status Verified: 2019-01
• Results First Submitted: 2019-01-07
• Results First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Results First Posted: 2019-01-29
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AO toric, then AOHG toric	Lotrafilcon B toric contact lenses	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.
AOHG toric, then AO toric	Lotrafilcon B toric contact lenses with HYDRAGLYDE	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.
AO toric, then AOHG toric	Lotrafilcon B toric contact lenses with HYDRAGLYDE	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.
AOHG toric, then AO toric	Lotrafilcon B toric contact lenses	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Johns Creek, Georgia, United States