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OpenTrials
Completed

NCT Number: NCT03384628

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visioncare research, Farnham, Surrey, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First pair Senofilcon A contact lens

Device

Fit assessment of the first pair contact lenses.

Second pair Senofilcon A contact lens

Device

Fit assessment of the second pair of contact lenses.

Third pair Senofilcon A contact lens

Device

Fit assessment of the third pair of contact lenses.

Primary outcomes

  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),

Sponsors and collaborators

Lead sponsor

Graeme Young

Other

Collaborators

  • Visioncare Research Ltd.

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2017
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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