PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

NCT ID: NCT04032457

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-08-02

Brief Summary

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The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .

The primary outcome variables for this study are subjective comfort and lens preference.

Detailed Description

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The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .

The primary outcome variables for this study are subjective comfort and lens preference.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over after 1 week of wear of two lens brands.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.

Study Groups

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A1 - SiHyDD to Moist

1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

A2 - Moist to SiHyDD

1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

A3 - SiHyDD to OASDD

1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

A4 - OASDD to SiHyDD

1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

A5 - SiHyDD to DT1

1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

A6 - DT1 to SiHyDD

1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase A - olifilcon B with Tangible Coatings

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lens

B1 - HydDD to Moist

1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

B2 - Moist to HydDD

1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

B3 - HydDD to BioTrue

1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

B4 - BioTrue to HydDD

1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

B5 - HydDD to AqCom+

1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

B6 - AqCom+ to HydDD

1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.

Group Type ACTIVE_COMPARATOR

Phase B - etafilcon A with Tangible Coatings

Intervention Type DEVICE

Daily disposable hydrogel contact lens

Interventions

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Phase A - olifilcon B with Tangible Coatings

Daily disposable silicone hydrogel contact lens

Intervention Type DEVICE

Phase B - etafilcon A with Tangible Coatings

Daily disposable hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy full-time wearers of spherical daily disposable contact lenses
* Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS
* Visual acuity corrected to at least 20/30 with spherical contact lens

Exclusion Criteria

* Participating in another clinical trial
* Vision not correctable to 20/30 with lens powers listed above
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foresight Regulatory Strategies, Inc.

INDUSTRY

Sponsor Role collaborator

Vision Service Plan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robin L Chalmers, OD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Consultant

Locations

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Ross Eyecare

Atlanta, Georgia, United States

Site Status

Professional Eye Care Center

Niles, Illinois, United States

Site Status

RevolutionEyes

Carmel, Indiana, United States

Site Status

Andover Optometry on Central

Andover, Massachusetts, United States

Site Status

Professional VisionCare

Westerville, Ohio, United States

Site Status

Primary Eyecare Group, PC

Brentwood, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VS-19-01

Identifier Type: -

Identifier Source: org_study_id

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