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Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT01912781
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Hyperopia Refractive Error Device: FID 120947A contact lens disinfecting solution Device: Boston Simplus multi-action solution Device: Gas permeable contact lenses Not Applicable

Detailed Description:
Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution in Gas Permeable Contact Lens Wearers
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: FID 120974A
FID 120947A contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Device: FID 120947A contact lens disinfecting solution
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses
Other Name: Clear Care® Plus

Device: Gas permeable contact lenses
Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).
Other Names:
  • Boston XO
  • Boston II

Active Comparator: Boston Simplus
Boston Simplus multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
Device: Boston Simplus multi-action solution
Commercially available solution indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses

Device: Gas permeable contact lenses
Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).
Other Names:
  • Boston XO
  • Boston II




Primary Outcome Measures :
  1. Percentage of Subjects With Visibly Clean Lenses [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.

  2. Percentage of Subjects With Crystalline Deposits by Type [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.

  3. Percentage of Subjects With Film Deposits by Type [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.

  4. Average Residual Lens Lysozyme [ Time Frame: Day 90/Early Exit ]
    Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.

  5. Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change [ Time Frame: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90 ]
    Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.

  6. Average Lens Wear Time [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.

  7. Number of Unscheduled Lens Replacements by Reason [ Time Frame: Up to Day 90 ]
    No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.

  8. Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day." [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.

  9. Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear." [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.

  10. Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling." [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.

  11. Crystalline Deposit Area Covered [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.

  12. Film Deposit Area Covered [ Time Frame: Day 7, Day 30, Day 60, Day 90 ]
    Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal eyes (other than correction for visual acuity);
  • Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;
  • Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
  • Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
  • Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
  • History of intolerance or hypersensitivity to any component of the investigational products;
  • Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
  • Moderate, severe, abnormal, or other ocular findings;
  • Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
  • Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
  • Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
  • Ocular surgery within the last 12 months;
  • Other protocol-defined 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): NCT01912781


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Lieve Convents, Lead CSM Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01912781     History of Changes
Other Study ID Numbers: C-13-004
First Posted: July 31, 2013    Key Record Dates
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015
Last Verified: June 2015
Keywords provided by Alcon Research:
contact lenses
contact lens solution
gas permeable contact lenses
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Hyperopia
Eye Diseases
Pharmaceutical Solutions