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Clinical Assessment of a HYDRAGLYDE® Regimen

Primary Purpose

Refractive Errors, Myopia, Hypermetropia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lotrafilcon B contact lenses with added wetting agent
Samfilcon A contact lenses
POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Hydrogen peroxide-based contact lens solution with added wetting agent
Senofilcon C contact lenses
Senofilcon A contact lenses
Comfilcon A contact lenses
Habitual Multi-Purpose Solution (HMPS)
Sponsored by
Alcon, a Novartis Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractive Errors

Eligibility Criteria

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

Inclusion Criteria:

  • Must sign informed consent document;
  • Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
  • Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye;
  • Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
  • Current user of an MPS (excluding OFPM) to care for lenses;
  • Willing to answer text messages on a daily basis during the study;
  • Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
  • Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
  • Other protocol specific inclusion criteria may apply.

Exclusion Criteria:

  • Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
  • Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
  • History of herpetic keratitis, corneal surgery or irregular cornea;
  • Prior refractive surgery;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
  • Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Known pregnancy or lactating;
  • Other protocol specific exclusion criteria may apply.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AOHG

Habitual

Arm Description

Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized

Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)

Outcomes

Primary Outcome Measures

Ex Vivo Total Cholesterol Uptake at Day 30
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2017
Last Updated
July 20, 2018
Sponsor
Alcon, a Novartis Company
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1. Study Identification

Unique Protocol Identification Number
NCT03026257
Brief Title
Clinical Assessment of a HYDRAGLYDE® Regimen
Official Title
Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
August 18, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Myopia, Hypermetropia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AOHG
Arm Type
Experimental
Arm Description
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
Arm Title
Habitual
Arm Type
Active Comparator
Arm Description
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lenses with added wetting agent
Other Intervention Name(s)
AIR OPTIX® plus HYDRAGLYDE® (AOHG)
Intervention Description
Silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Samfilcon A contact lenses
Other Intervention Name(s)
Bausch + Lomb ULTRA™ (Ultra)
Intervention Description
Habitual silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
Other Intervention Name(s)
OPTI-FREE® PureMoist® (OFPM)
Intervention Description
Multi-purpose disinfecting solution for contact lens care
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide-based contact lens solution with added wetting agent
Other Intervention Name(s)
CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
Intervention Description
Solution for contact lens cleaning and disinfecting
Intervention Type
Device
Intervention Name(s)
Senofilcon C contact lenses
Other Intervention Name(s)
Johnson & Johnson ACUVUE® VITA™ (Vita)
Intervention Description
Habitual silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)
Intervention Description
Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
CooperVision® Biofinity® (Biofinity)
Intervention Description
Habitual silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Habitual Multi-Purpose Solution (HMPS)
Intervention Description
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
Primary Outcome Measure Information:
Title
Ex Vivo Total Cholesterol Uptake at Day 30
Description
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must sign informed consent document; Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses; Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye; Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available; Current user of an MPS (excluding OFPM) to care for lenses; Willing to answer text messages on a daily basis during the study; Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits; Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study; Other protocol specific inclusion criteria may apply. Exclusion Criteria: Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week); Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear; History of herpetic keratitis, corneal surgery or irregular cornea; Prior refractive surgery; Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days; Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Known pregnancy or lactating; Other protocol specific exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Global Med Affairs, GCRA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alcon Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Alcon Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Alcon Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Alcon Investigative Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada
Facility Name
Alcon Investigative Site
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Alcon Investigative Site
City
Jena
ZIP/Postal Code
07745
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32769842
Citation
Shows A, Redfern RL, Sickenberger W, Fogt JS, Schulze M, Lievens C, Szczotka-Flynn L, Schwarz S, Tichenor AA, Marx S, Lemp-Hull JM. Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial. Optom Vis Sci. 2020 Aug;97(8):565-572. doi: 10.1097/OPX.0000000000001553.
Results Reference
derived

Learn more about this trial

Clinical Assessment of a HYDRAGLYDE® Regimen

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