On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours

NCT ID: NCT03881670

Last Updated: 2020-03-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2019-02-08

Brief Summary

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The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.

Detailed Description

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Conditions

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Hyperopia Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lotrafilcon B

Group Type PLACEBO_COMPARATOR

Lotrafilcon B

Intervention Type DEVICE

commercially available contact lens

lotrafilcon B with Hydraluxe

Intervention Type DEVICE

commercially available contact lens

Lotrafilcon B Hydraluxe

Group Type ACTIVE_COMPARATOR

Lotrafilcon B

Intervention Type DEVICE

commercially available contact lens

lotrafilcon B with Hydraluxe

Intervention Type DEVICE

commercially available contact lens

Interventions

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Lotrafilcon B

commercially available contact lens

Intervention Type DEVICE

lotrafilcon B with Hydraluxe

commercially available contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Habitual prescription +5.00 D to -6.00 D
* 18-35 years of age
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Vertex corrected refractive cylinder must be -0.75 or less.
* Visual acuity best correctable to 20/25 or better for each eye
* The subject must read and sign the Informed Consent form.
* Mesopic pupil size \>5.00 mm.

Exclusion Criteria

* active condition that would prevent contact lens wear
* history of issues of eye alignment or binocularity by self-report
* doctor diagnosed, self-reported accommodative or binocular vision issues
* doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Pete Kollbaum, OD, PhD

Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University Clinical Optics Research Lab

Bloomington, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Kollbaum002

Identifier Type: -

Identifier Source: org_study_id

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