Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses

NCT ID: NCT02142361

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-07-31

Brief Summary

Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Detailed Description

This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.

Conditions

Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Omafilcon A/Enfilcon A

Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.

Group Type: ACTIVE_COMPARATOR

enfilcon A

Intervention Type: DEVICE

Silicone hydrogel toric lenses.

Ocufilcon D/Enfilcon A

Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.

Group Type: ACTIVE_COMPARATOR

enfilcon A

Intervention Type: DEVICE

Silicone hydrogel toric lenses.

Methafilcon B/ Enfilcon A

Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses.

Group Type: ACTIVE_COMPARATOR

enfilcon A

Intervention Type: DEVICE

Silicone hydrogel toric lenses.

Interventions

enfilcon A

Silicone hydrogel toric lenses.

Intervention Type: DEVICE

Other Intervention Names

enfilcon A/Silicone Hydrogel Lens

Eligibility Criteria

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 soft toric contact lens wearer
• Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)
• Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes.
• 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

• Has a contact lens prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
• Has a history of not achieving comfortable contact lens 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Montés-Mico, OD MPhil PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Valencia, , Spain

Countries

Spain

Other Identifiers

EX-MKTG-48

Identifier Type: -

Identifier Source: org_study_id