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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
First pair Senofilcon A contact lens
Second pair Senofilcon A contact lens
Third pair Senofilcon A contact lens
Sponsored by
Graeme Young
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Contact lens, The Young Theory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Visioncare research
  • Aston University Optometry Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

First Pair Senofilcon A contact lens

Second pair Senofilcon A contact lens

Third pair Senofilcon A contact lens

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Lens fit (position on the eye) in mm
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),
Lens edge tightness fit grade 0-4
Edge tightness (grade 0-4)
Lens tightness fit graded as %
Tightness (push-up %),
Lens overall fit grade 0-5
Overall fit acceptability (Grade 0-5),

Secondary Outcome Measures

Full Information

First Posted
December 8, 2017
Last Updated
June 6, 2018
Sponsor
Graeme Young
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03384628
Brief Title
An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Official Title
An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Graeme Young
Collaborators
Visioncare Research Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Contact lens, The Young Theory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each subject will wear the three contact lens types bilaterally in random succession
Masking
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.
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Pair Senofilcon A contact lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Second pair Senofilcon A contact lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Third pair Senofilcon A contact lens
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
First pair Senofilcon A contact lens
Intervention Description
Fit assessment of the first pair contact lenses.
Intervention Type
Device
Intervention Name(s)
Second pair Senofilcon A contact lens
Intervention Description
Fit assessment of the second pair of contact lenses.
Intervention Type
Device
Intervention Name(s)
Third pair Senofilcon A contact lens
Intervention Description
Fit assessment of the third pair of contact lenses.
Primary Outcome Measure Information:
Title
Lens fit (position on the eye) in mm
Description
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),
Time Frame
25 minutes
Title
Lens edge tightness fit grade 0-4
Description
Edge tightness (grade 0-4)
Time Frame
5 minutes
Title
Lens tightness fit graded as %
Description
Tightness (push-up %),
Time Frame
5 minutes
Title
Lens overall fit grade 0-5
Description
Overall fit acceptability (Grade 0-5),
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Young, PhD MPhil
Organizational Affiliation
Managing director
Official's Role
Study Director
Facility Information:
Facility Name
Visioncare research
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
Facility Name
Aston University Optometry Clinic
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 7ET
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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