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Comparison of Two Silicone Hydrogel Toric Contact Lenses

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lotrafilcon B toric contact lenses with HYDRAGLYDE
Lotrafilcon B toric contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Astigmatism focused on measuring Astigmatism, Axis orientation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

AOHG toric, then AO toric

AO toric, then AOHG toric

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2018
Last Updated
January 7, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03392532
Brief Title
Comparison of Two Silicone Hydrogel Toric Contact Lenses
Official Title
Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Astigmatism, Axis orientation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AOHG toric, then AO toric
Arm Type
Other
Arm Description
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.
Arm Title
AO toric, then AOHG toric
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B toric contact lenses with HYDRAGLYDE
Other Intervention Name(s)
AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses, AOHG for Astigmatism
Intervention Description
Silicone hydrogel soft contact lenses for astigmatism
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B toric contact lenses
Other Intervention Name(s)
AIR OPTIX® for Astigmatism contact lenses, AO for Astigmatism
Intervention Description
Silicone hydrogel soft contact lenses for astigmatism
Primary Outcome Measure Information:
Title
Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)
Description
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.
Time Frame
Day 1, 10 minutes after lens insertion, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Two Silicone Hydrogel Toric Contact Lenses

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