Comparison of Two Silicone Hydrogel Toric Contact Lenses

NCT ID: NCT03392532

Last Updated: 2019-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2018-01-26

Brief Summary

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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

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

Lotrafilcon B toric contact lenses with HYDRAGLYDE

Intervention Type DEVICE

Silicone hydrogel soft contact lenses for astigmatism

Lotrafilcon B toric contact lenses

Intervention Type DEVICE

Silicone hydrogel soft contact lenses for astigmatism

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.

Group Type OTHER

Lotrafilcon B toric contact lenses with HYDRAGLYDE

Intervention Type DEVICE

Silicone hydrogel soft contact lenses for astigmatism

Lotrafilcon B toric contact lenses

Intervention Type DEVICE

Silicone hydrogel soft contact lenses for astigmatism

Interventions

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Lotrafilcon B toric contact lenses with HYDRAGLYDE

Silicone hydrogel soft contact lenses for astigmatism

Intervention Type DEVICE

Lotrafilcon B toric contact lenses

Silicone hydrogel soft contact lenses for astigmatism

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses AOHG for Astigmatism AIR OPTIX® for Astigmatism contact lenses AO for Astigmatism

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alcon, A Novartis Division

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Locations

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Alcon Investigative Site

Johns Creek, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLC127-C001

Identifier Type: -

Identifier Source: org_study_id

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