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

CooperVision, Inc.35 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

filcon IV I (BC 8.6)DEVICE

control lens

filcon IV I (BC 8.7)DEVICE

control lens

ocufilcon DDEVICE

test lens

methafilcon A (BC 8.6)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Outcomes

Primary Outcomes

Centration - Pair One

Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Time frame: Baseline and 1 hour

Centration - Pair Two

Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Time frame: Baseline and 1 hour

Centration - Pair Three

Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Time frame: Baseline and 1 hour

Centration - Pair Four

Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).

Time frame: Baseline and 1 hour

Post-blink Movement - Pair One

Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Time frame: Baseline

Post-blink Movement - Pair One

Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Time frame: 1 hour

Post-blink Movement - Pair Two

Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.