Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

NCT ID: NCT01965288

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-05-31

Brief Summary

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Detailed Description

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

comfilcon A

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

lotrafilcon B

Intervention Type: DEVICE

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

lotrafilcon B

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Group Type: ACTIVE_COMPARATOR

comfilcon A

Intervention Type: DEVICE

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

lotrafilcon B

Intervention Type: DEVICE

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Interventions

comfilcon A

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Intervention Type: DEVICE

lotrafilcon B

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Intervention Type: DEVICE

Other Intervention Names

Biofinity Toric; Air Optix

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

• 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 - 10.00 (inclusive)
• Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D 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

A person will be excluded from the study if he/she:

• 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 -2.25 D 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-42

Identifier Type: -

Identifier Source: org_study_id