Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Myopia Clinical Trial

Official title:

Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815735
• Other study ID #: EX-MKTG-68 (VISA-407)
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: March 1, 2017
• Start date: August 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Description:

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)

• Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*

• Spectacle cylinder 0.75D in both eyes

• Correctable to 6/9 in both eyes

• Be between 18 and 34 years of age (inclusive)

• Able to read, comprehend and sign an informed consent

• Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm

• Willing to comply with the wear and study visit schedule

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

• Existing wearer of daily disposable contact lenses

• Known allergy to Opti-Free PureMoist multipurpose solution

• Any active corneal infection, injury or inflammation

• Systemic or ocular allergies, which might interfere with CL wear

• Systemic disease, which might interfere with CL wear

• Ocular disease, which might interfere with CL wear

• Strabismus or amblyopia

• Subjects who have undergone corneal refractive surgery

• Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

• Pregnant, planning a pregnancy or lactating

• Use of systemic/topical medication contraindicating CL wear

• Diabetic

• Site employees or family members of investigators

• Participation in any concurrent trial or in the last 30 days

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
contact lens
• lotrafilcon B
contact lens

Locations

Country	Name	City	State
United Kingdom	Boots Opticians Ltd	Birmingham	Warwickshire
United Kingdom	Tempany's Boutique Opticians	Broadstone	Dorset
United Kingdom	Chalmers Opticians	Cardiff	Glamorgan
United Kingdom	Brock and Houlford	Chew Magna	Bristol
United Kingdom	Visioncare Research Ltd.	Farnham
United Kingdom	David Gould Opticians	Rawtenstall	Lancashire
United Kingdom	Eyesite	Reading	Berkshire
United Kingdom	Leightons	St Albans	Hertfordshire
United Kingdom	Harrold Opticians	Uxbridge	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Comfort (insertion, end of the day, and overall) for comfilcon A and lotrafilcon B lenses assessed. Scale 0-10, 0=painful, 10=can't feel the lenses.	Up to 4 weeks
Primary	Comfort during the day	Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message. Scale 0-10, 0=painful, 10=can't feel the lenses.	Up to 4 weeks