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An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.

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: NCT03384628
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Graeme Young, Visioncare Research Ltd.

Brief Summary:
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.

Condition or disease Intervention/treatment Phase
Myopia Device: First pair Senofilcon A contact lens Device: Second pair Senofilcon A contact lens Device: Third pair Senofilcon A contact lens Not Applicable

Detailed Description:
This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each subject will wear the three contact lens types bilaterally in random succession
Masking: Single (Participant)
Masking Description: Subjects will be masked to lens type and lens codes. A sealed decoding envelope will be provided to the investigator. In the event of an emergency the investigator will break the masking and the medical monitor will be notified.
Primary Purpose: Treatment
Official Title: An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Seizures

Arm Intervention/treatment
Active Comparator: First Pair Senofilcon A contact lens
The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal.
Device: First pair Senofilcon A contact lens
Fit assessment of the first pair contact lenses.

Active Comparator: Second pair Senofilcon A contact lens
The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal.
Device: Second pair Senofilcon A contact lens
Fit assessment of the second pair of contact lenses.

Active Comparator: Third pair Senofilcon A contact lens
The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal.
Device: Third pair Senofilcon A contact lens
Fit assessment of the third pair of contact lenses.




Primary Outcome Measures :
  1. Lens fit (position on the eye) in mm [ Time Frame: 25 minutes ]
    Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm),

  2. Lens edge tightness fit grade 0-4 [ Time Frame: 5 minutes ]
    Edge tightness (grade 0-4)

  3. Lens tightness fit graded as % [ Time Frame: 5 minutes ]
    Tightness (push-up %),

  4. Lens overall fit grade 0-5 [ Time Frame: 5 minutes ]
    Overall fit acceptability (Grade 0-5),



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-70 years.
  • Able to read, comprehend and sign an informed consent.
  • Willing to comply with the wear and study assessment schedule.
  • Spherical distance prescription between -0.50 and -6.00 (inc.).
  • Astigmatism, if present,≤1.50DC in both eyes.
  • Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:

A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).

Exclusion Criteria:

  • Previous anterior ocular surgery
  • Any active corneal infection, injury or inflammation

    . •Large pinguecula likely to affect soft lens fit

  • Systemic or ocular disease or medication which might interfere with CL wear
  • Pregnancy or breastfeeding
  • Participation in any concurrent trial

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): NCT03384628


Locations
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United Kingdom
Visioncare research
Farnham, Surrey, United Kingdom, GU9 7EN
Aston University Optometry Clinic
Birmingham, West Midlands, United Kingdom, B4 7ET
Sponsors and Collaborators
Graeme Young
Visioncare Research Ltd.
Investigators
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Study Director: Graeme Young, PhD MPhil Managing director
  Study Documents (Full-Text)

Documents provided by Graeme Young, Visioncare Research Ltd.:
Study Protocol  [PDF] August 25, 2017
Informed Consent Form  [PDF] November 6, 2017
Statistical Analysis Plan  [PDF] December 18, 2017


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Responsible Party: Graeme Young, Graeme Young PhD MPhil FCOptom DCLP, Visioncare Research Ltd.
ClinicalTrials.gov Identifier: NCT03384628    
Other Study ID Numbers: TRTN-501
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: April 2018
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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Graeme Young, Visioncare Research Ltd.:
Contact lens
The Young Theory
Additional relevant MeSH terms:
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Seizures
Myopia
Refractive Errors
Eye Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms