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PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses (PAVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032457
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Foresight Regulatory Strategies, Inc.
Information provided by (Responsible Party):
Vision Service Plan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Refractive Errors Device: Phase A - olifilcon B with Tangible Coatings Device: Phase B - etafilcon A with Tangible Coatings Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized cross-over after 1 week of wear of two lens brands.
Masking: Single (Care Provider)
Masking Description: Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
Primary Purpose: Treatment
Official Title: PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens

Active Comparator: 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.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Active Comparator: 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.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Active Comparator: B3 - HydDD to BioTrue
1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Active Comparator: B4 - BioTrue to HydDD
1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Active Comparator: B5 - HydDD to AqCom+
1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Active Comparator: B6 - AqCom+ to HydDD
1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens




Primary Outcome Measures :
  1. Subjective Lens Preference [ Time Frame: Visit 3 - Approximately 2 weeks ]
    Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.


Secondary Outcome Measures :
  1. 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score [ Time Frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively ]
    Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032457


Contacts
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Contact: Robin L Chalmers, OD 678-427-6986 chalmers2097@gmail.com
Contact: Jeff Adams 916-397-5231 jeff.adams@vsp.com

Locations
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United States, Georgia
Ross Eyecare Recruiting
Atlanta, Georgia, United States, 30324
Contact: Stephanie M Ross, OD    404-233-3513    sross@rosseyecare.com   
United States, Illinois
Professional Eye Care Center Recruiting
Niles, Illinois, United States, 60714
Contact: Justin T Kwan, OD    847-647-0707    Justin.t.kwan@gmail.com   
United States, Indiana
RevolutionEyes Recruiting
Carmel, Indiana, United States, 46032
Contact: Katherine Schuetz, OD    317-844-2020    drschuetz@revolution-eyes.com   
United States, Massachusetts
Andover Optometry on Central Recruiting
Andover, Massachusetts, United States, 01810
Contact: Ronald Watanabe, OD    978-475-5252    drwatanabe@andoveroptometry.com   
United States, Ohio
Professional VisionCare Not yet recruiting
Westerville, Ohio, United States, 43081
Contact: William G Lay, OD    614-898-9989    blay@ohiovisioncare.com   
United States, Tennessee
Primary Eyecare Group, PC Recruiting
Brentwood, Tennessee, United States, 37027
Contact: Peter Van Hoven, OD    615-373-0080    PVanHoven@primaryeyecare.com   
Sponsors and Collaborators
Vision Service Plan
Foresight Regulatory Strategies, Inc.
Investigators
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Principal Investigator: Robin L Chalmers, OD Clinical Trial Consultant

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Responsible Party: Vision Service Plan
ClinicalTrials.gov Identifier: NCT04032457     History of Changes
Other Study ID Numbers: VS-19-01
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vision Service Plan:
Contact Lens
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases