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The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

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: NCT02801006
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : December 12, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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Brief Summary:
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

Condition or disease Intervention/treatment Phase
Astigmatism Device: stenfilcon A Device: etafilcon A Not Applicable

Detailed Description:
This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 31, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: stenfilcon A
Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.
 Device: stenfilcon A
contact lens
Active Comparator: etafilcon A
Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.
 Device: etafilcon A
contact lens


Outcome Measures
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Primary Outcome Measures :
  1. Comfort [ Time Frame: 2 weeks ]
    Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

  2. Dryness [ Time Frame: 2 weeks ]
    Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

  3. Clarity of Vision [ Time Frame: 2 weeks ]
    Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

  4. Stability of Vision [ Time Frame: 2 weeks ]
    Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

  5. Lens Handling [ Time Frame: 2 weeks ]
    Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

  6. Overall Satisfaction [ Time Frame: 2 weeks ]
    Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between 18 years of age and 42 years of age.
  • Soft contact lens wearers who are not required to have Presbyopic correction.
  • Soft contact lens wearers without trouble.
  • Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
  • Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
  • Can achieve a corrected visual acuity of 1.0 or better.
  • Can read and understand the study information document, and sign the participation consent form.
  • Can visit the clinic at designated examination visits.
  • Has received periodical examinations at an eye clinic within the past two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Has a systemic disease that may affect the ocular health.
  • Is pregnant or lactating.
  • Has received a systemic or local medication that may affect this study.
  • Has an infectious eye disease.
  • Has eye and systemic active allergic diseases that interferes with SCL wear.
  • Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
  • Has a history of hard contact lens wear within 30 days.
  • Is currently participating in another clinical research study.
  • Has undergone refractive surgery.
Contacts and Locations
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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): NCT02801006


Locations
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Japan
Kodama Eye Clinic
Terada, Kyoto, Japan, 610-0121
Dougenzaka Ioti Eye Clinic
Shibuya, Tokyo-to, Japan, 150-0043
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Yuji Kodama, MD, PhD Director, Kodama Eye Clinic
More Information
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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT02801006    
Other Study ID Numbers: JP-MKTG-201603
First Posted: June 15, 2016    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: January 9, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases