Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02248727
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: somofilcon A	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: enfilcon A All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens	Device: somofilcon A; somofilcon A lens
Experimental: somofilcon A All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens	Device: somofilcon A; somofilcon A lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity - Enfilcon A and Somofilcon A [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.

2. Subjective Assessments. - Enfilcon A and Somofilcon A [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Research Group (GIO) Optics Department, University of Valencia	Valencia		Spain	46100

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Robert Montés-Mico, O.D., Optometry Research Group (GIO) University of Valencia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02248727
• Other Study ID Numbers: EX-MKTG-52
• First Posted: Sep 25, 2014
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Enfilcon A / Somofilcon A
Arm/Group Description	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Enfilcon A / Somofilcon A
Arm/Group Description	All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.10 (2.02)
Sex: Female, Male (Count of Participants)
Female	20 66.7%
Male	10 33.3%
Region of Enrollment (participants) [Number]
Spain	30 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity - Enfilcon A and Somofilcon A
Description	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.
Time Frame	Baseline, 1 Week, 2 Week, 4 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enfilcon A	Somofilcon A at 1 Week	Somofilcon A at 2 Week	Somofilcon A at 4 Week
Arm/Group Description	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
Measure Participants	30	30	30	30
OD	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)
OS	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)
Binocular	-0.067 (0.066)	-0.067 (0.066)	-0.067 (0.066)	-0.067 (0.066)

2. Primary Outcome

Title	Subjective Assessments. - Enfilcon A and Somofilcon A
Description	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)
Time Frame	Baseline, 1 Week, 2 Week, 4 Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enfilcon A	Somofilcon A at 1 Week	Somofilcon A at 2 Week	Somofilcon A at 4 Week
Arm/Group Description	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.	All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
Measure Participants	30	30	30	30
Comfort on insertion	8.43 (0.77)	7.73 (0.83)	7.33 (0.76)	6.80 (0.81)
Comfort prior to removal	8.53 (0.73)	7.20 (1.16)	6.90 (1.03)	6.50 (0.94)
Overall comfort	8.47 (0.82)	7.40 (0.97)	7.07 (0.98)	6.60 (0.93)
Dryness during the day	8.33 (0.84)	8.17 (0.95)	7.63 (1.07)	6.97 (1.07)
Dryness prior to removal	8.47 (0.86)	7.77 (1.04)	7.27 (1.05)	6.80 (1.16)
Overall dryness	8.40 (0.89)	7.43 (1.07)	7.13 (0.97)	6.77 (1.14)
Handling	8.50 (0.68)	7.70 (1.15)	7.07 (0.94)	6.40 (0.93)
Overall vision satifaction	8.47 (0.78)	8.37 (0.81)	8.10 (0.92)	7.53 (0.78)
Habitual eye whiteness	8.40 (0.81)	8.23 (0.73)	8.17 (0.87)	7.73 (0.83)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Enfilcon A to Somofilcon A
Arm/Group Description	All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens
All Cause Mortality
	Enfilcon A to Somofilcon A
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enfilcon A to Somofilcon A
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Enfilcon A to Somofilcon A
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.