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

NCT03384628 | Completed

• 1 other identifier: TRTN-501
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Myopia

Keywords

Contact lens; The Young Theory

Outcome Measures

Primary Outcomes (4)

• 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),

  25 minutes

• Lens edge tightness fit grade 0-4

  Edge tightness (grade 0-4)

  5 minutes

• Lens tightness fit graded as %

  Tightness (push-up %),

  5 minutes

• Lens overall fit grade 0-5

  Overall fit acceptability (Grade 0-5),

  5 minutes

Study Arms (3)

First Pair Senofilcon A contact lens

ACTIVE COMPARATOR

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

Second pair Senofilcon A contact lens

ACTIVE COMPARATOR

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

Third pair Senofilcon A contact lens

ACTIVE COMPARATOR

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

Interventions

First pair Senofilcon A contact lens DEVICE

Fit assessment of the first pair contact lenses.

First Pair Senofilcon A contact lens

Second pair Senofilcon A contact lens DEVICE

Fit assessment of the second pair of contact lenses.

Second pair Senofilcon A contact lens

Third pair Senofilcon A contact lens DEVICE

Fit assessment of the third pair of contact lenses.

Third pair Senofilcon A contact lens

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Graeme Young: lead
• Visioncare Research Ltd.: collaborator

Study Sites (2)

Visioncare research

Farnham, Surrey, GU9 7EN, United Kingdom

Location

Aston University Optometry Clinic

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Graeme Young, PhD MPhil

  Managing director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graeme Young PhD MPhil FCOptom DCLP

Model Details: Each subject will wear the three contact lens types bilaterally in random succession

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 27, 2017
• Study Start: January 26, 2018
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: June 7, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)