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Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699684
Recruitment Status : Completed
First Posted : March 4, 2016
Results First Posted : September 7, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Lotrafilcon B contact lenses with EOBO-41 Device: Lotrafilcon B contact lenses Device: Hydrogen peroxide-based lens care solution Device: Saline solution for rinsing contact lenses Device: Saline solution for rinsing contact lens case Not Applicable

Detailed Description:
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : October 20, 2016
Actual Study Completion Date : October 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Device: Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE®
  • AOHG

Device: Lotrafilcon B contact lenses
Lotrafilcon B contact lenses packaged with copolymer 845
Other Names:
  • AIR OPTIX® AQUA
  • AOA

Device: Hydrogen peroxide-based lens care solution
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
Other Names:
  • AOSEPT® PLUS
  • CLEAR CARE® PLUS

Device: Saline solution for rinsing contact lenses
Commercially-available saline solution used as needed
Other Name: Minims®

Device: Saline solution for rinsing contact lens case
Commercially-available solution used as needed
Other Name: LENS PLUS® OCUPURE™

AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Device: Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other Names:
  • AIR OPTIX® plus HYDRAGLYDE®
  • AOHG

Device: Lotrafilcon B contact lenses
Lotrafilcon B contact lenses packaged with copolymer 845
Other Names:
  • AIR OPTIX® AQUA
  • AOA

Device: Hydrogen peroxide-based lens care solution
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
Other Names:
  • AOSEPT® PLUS
  • CLEAR CARE® PLUS

Device: Saline solution for rinsing contact lenses
Commercially-available saline solution used as needed
Other Name: Minims®

Device: Saline solution for rinsing contact lens case
Commercially-available solution used as needed
Other Name: LENS PLUS® OCUPURE™




Primary Outcome Measures :
  1. Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes [ Time Frame: Day 30, each product ]
    Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.


Secondary Outcome Measures :
  1. Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear [ Time Frame: Day 30, each product ]
    The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.

  2. Change From Insertion in Minimum Protected Area (MPA) [ Time Frame: Hour 0 (Lens Insertion) to Hour 12 on Day 1 ]
    MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must sign Informed Consent Document;
  • Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
  • Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
  • Willing to answer text messages on a daily basis during the study;
  • Willing to discontinue artificial tears and rewetting drops on the days of study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
  • Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
  • History of herpetic keratitis, corneal surgery or irregular cornea;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Pregnant or lactating;
  • Participation in any clinical study within 30 days of Visit 1;
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699684


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Trial Manager, EMEA Alcon, A Novartis Division
Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02699684    
Other Study ID Numbers: CLE270-P001
First Posted: March 4, 2016    Key Record Dates
Results First Posted: September 7, 2017
Last Update Posted: July 2, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases
Hydrogen Peroxide
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents