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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

Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE July 25, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
Subjective Lens Preference [ Time Frame: Visit 3 - Approximately 2 weeks ]
Subjective preference for either lens intervention or no preference.
Change History Complete list of historical versions of study NCT04032457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Official Title  ICMJE PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Refractive Errors
Intervention  ICMJE
  • Device: Phase A - olifilcon B with Tangible Coatings
    Daily disposable silicone hydrogel contact lens
  • Device: Phase B - etafilcon A with Tangible Coatings
    Daily disposable hydrogel contact lens
Study Arms  ICMJE
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase A - olifilcon B with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
  • 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.
    Intervention: Device: Phase B - etafilcon A with Tangible Coatings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2019)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robin L Chalmers, OD 678-427-6986 chalmers2097@gmail.com
Contact: Jeff Adams 916-397-5231 jeff.adams@vsp.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04032457
Other Study ID Numbers  ICMJE VS-19-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vision Service Plan
Study Sponsor  ICMJE Vision Service Plan
Collaborators  ICMJE Foresight Regulatory Strategies, Inc.
Investigators  ICMJE
Principal Investigator: Robin L Chalmers, OD Clinical Trial Consultant
PRS Account Vision Service Plan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP