Proclear 1-D Multifocal Nondispensing Study

NCT ID: NCT01526902

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-05-31

Brief Summary

This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

Detailed Description

The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Conditions

Presbyopia

Study Design

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

Study Groups

omafilcon A / PC 1-D MF

omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Group Type: ACTIVE_COMPARATOR

omafilcon A / PC 1-D MF

Intervention Type: DEVICE

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

lotrafilcon B / Air Optix MF

Intervention Type: DEVICE

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses

lotrafilcon B / Air Optix MF

lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Group Type: ACTIVE_COMPARATOR

omafilcon A / PC 1-D MF

Intervention Type: DEVICE

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

lotrafilcon B / Air Optix MF

Intervention Type: DEVICE

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses

Interventions

omafilcon A / PC 1-D MF

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Intervention Type: DEVICE

lotrafilcon B / Air Optix MF

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses

Intervention Type: DEVICE

Other Intervention Names

Proclear Multifocal daily wear soft contact lenses; Air OPtix Aqua Multifocal extended wear soft contact lenses

Eligibility Criteria

Inclusion Criteria

• Be between 40 and 65 years of age (inclusive)
• Require a reading addition of +1.25 to +2.50D (inclusive)
• Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
• Spectacle cylinder less than or equal to 0.75D in both eyes.
• Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
• Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
• Have a minimum 2 weeks soft contact lens experience
• Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
• Able to read, comprehend and sign an informed consent
• Willing to comply with the wear and study visit schedule
• Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
• No gas permeable contact lens wear for 1 month prior to the study

Exclusion Criteria

To be eligible for the study, each candidate must not present with any of the following

• Any active corneal infection, injury, inflammation, or ocular abnormality
• Systemic or ocular allergies, which might interfere with contact lens wear
• Systemic disease, which might interfere with contact lens wear
• Ocular disease, which might interfere with contact lens wear
• Pregnant or lactating
• Strabismus/amblyopia
• Habitually uncorrected anisometropia greater than or equal to 2.00 D
• Subjects who have undergone corneal refractive surgery
• Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kollbaum, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

Locations

Clinical Optics Research Lab, Indiana University,

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

CV-12-02A

Identifier Type: -

Identifier Source: org_study_id