- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248727
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere
July 19, 2020 updated by: Coopervision, Inc.
Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.
Study Overview
Detailed Description
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses.
Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear.
After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Valencia, Spain, 46100
- Optometry Research Group (GIO) Optics Department, University of Valencia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
- Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D in each eye.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria:
- Is not a habitual wearer of Avaira sphere lenses
- Has a contact lens prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: enfilcon A
All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
|
somofilcon A lens
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Experimental: somofilcon A
All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
|
somofilcon A lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity - Enfilcon A and Somofilcon A
Time Frame: Baseline, 1 Week, 2 Week, 4 Week
|
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
|
Baseline, 1 Week, 2 Week, 4 Week
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Subjective Assessments. - Enfilcon A and Somofilcon A
Time Frame: Baseline, 1 Week, 2 Week, 4 Week
|
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness.
Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
|
Baseline, 1 Week, 2 Week, 4 Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Montés-Mico, O.D., Optometry Research Group (GIO) University of Valencia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 24, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 19, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX-MKTG-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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