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

NCT02248727 | Completed Results

• 1 other identifier: EX-MKTG-52
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Visual Acuity - Enfilcon A and Somofilcon A

  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

• Subjective Assessments. - Enfilcon A and Somofilcon A

  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

Study Arms (2)

enfilcon A

ACTIVE COMPARATOR

All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens

Device: somofilcon A

somofilcon A

EXPERIMENTAL

All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens

Device: somofilcon A

Interventions

somofilcon A DEVICE

somofilcon A lens

enfilcon A; somofilcon A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Research Group (GIO) Optics Department, University of Valencia

Valencia, 46100, Spain

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Montes-Mico, O.D., PhD
• Organization: Optometry Research Group (GIO) University of Valencia

robert.montes@uv.es

34-9635-44764

Study Officials

• Robert Montés-Mico, O.D.

  Optometry Research Group (GIO) University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 28, 2020
• Results First Posted: March 23, 2016

Record last verified: 2020-07

Locations

ES (1)