Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

NCT ID: NCT02727816

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

Brief Summary

The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Detailed Description

This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:

Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

filcon IV I (BC 8.6) / ocufilcon D (pair one)

Participants were randomized to a test and control lens for each pair in a contralateral design.

Group Type: EXPERIMENTAL

filcon IV I (BC 8.6)

Intervention Type: DEVICE

control lens

ocufilcon D

Intervention Type: DEVICE

test lens

filcon IV I (BC 8.7) / ocufilcon D (pair two)

Participants were randomized to a test and control lens for each pair in a contralateral design.

Group Type: EXPERIMENTAL

filcon IV I (BC 8.7)

Intervention Type: DEVICE

control lens

ocufilcon D

Intervention Type: DEVICE

test lens

methafilcon A (BC 8.6) / ocufilcon D (pair three)

Participants were randomized to a test and control lens for each pair in a contralateral design.

Group Type: EXPERIMENTAL

ocufilcon D

Intervention Type: DEVICE

test lens

methafilcon A (BC 8.6)

Intervention Type: DEVICE

control lens

methafilcon A (BC 8.7) / somofilcon A (pair four)

Participants were randomized to a test and control lens for each pair in a contralateral design.

Group Type: EXPERIMENTAL

methafilcon A (BC 8.7)

Intervention Type: DEVICE

control lens

somofilcon A

Intervention Type: DEVICE

test lens

Interventions

filcon IV I (BC 8.6)

control lens

Intervention Type: DEVICE

filcon IV I (BC 8.7)

control lens

Intervention Type: DEVICE

ocufilcon D

test lens

Intervention Type: DEVICE

methafilcon A (BC 8.6)

control lens

Intervention Type: DEVICE

methafilcon A (BC 8.7)

control lens

Intervention Type: DEVICE

somofilcon A

test lens

Intervention Type: DEVICE

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 CL (Contact Lens) wearer.
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (Diopters) 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.
• Is willing to comply with the visit schedule.

Exclusion Criteria

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

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to - 6.00D
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• 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 (GPC) 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: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Optometry Clinic, National Autonomous University

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

EX-MKTG-65

Identifier Type: -

Identifier Source: org_study_id