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

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase A - olifilcon B with Tangible Coatings
Phase B - etafilcon A with Tangible Coatings
Sponsored by
Vision Service Plan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lens

Eligibility Criteria

18 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ross Eyecare
  • Professional Eye Care Center
  • RevolutionEyes
  • Andover Optometry on Central
  • Professional VisionCare
  • Primary Eyecare Group, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

A1 - SiHyDD to Moist

A2 - Moist to SiHyDD

A3 - SiHyDD to OASDD

A4 - OASDD to SiHyDD

A5 - SiHyDD to DT1

A6 - DT1 to SiHyDD

B1 - HydDD to Moist

B2 - Moist to HydDD

B3 - HydDD to BioTrue

B4 - BioTrue to HydDD

B5 - HydDD to AqCom+

B6 - AqCom+ to HydDD

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Subjective Lens Preference
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

8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
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.

Full Information

First Posted
April 17, 2019
Last Updated
October 5, 2020
Sponsor
Vision Service Plan
Collaborators
Foresight Regulatory Strategies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04032457
Brief Title
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Acronym
PAVES
Official Title
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vision Service Plan
Collaborators
Foresight Regulatory Strategies, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over after 1 week of wear of two lens brands.
Masking
Care Provider
Masking Description
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1 - SiHyDD to Moist
Arm Type
Active Comparator
Arm Description
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Arm Title
A2 - Moist to SiHyDD
Arm Type
Active Comparator
Arm Description
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Arm Title
A3 - SiHyDD to OASDD
Arm Type
Active Comparator
Arm Description
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
Arm Title
A4 - OASDD to SiHyDD
Arm Type
Active Comparator
Arm Description
1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Arm Title
A5 - SiHyDD to DT1
Arm Type
Active Comparator
Arm Description
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
Arm Title
A6 - DT1 to SiHyDD
Arm Type
Active Comparator
Arm Description
1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Arm Title
B1 - HydDD to Moist
Arm Type
Active Comparator
Arm Description
1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Arm Title
B2 - Moist to HydDD
Arm Type
Active Comparator
Arm Description
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Arm Title
B3 - HydDD to BioTrue
Arm Type
Active Comparator
Arm Description
1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
Arm Title
B4 - BioTrue to HydDD
Arm Type
Active Comparator
Arm Description
1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Arm Title
B5 - HydDD to AqCom+
Arm Type
Active Comparator
Arm Description
1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
Arm Title
B6 - AqCom+ to HydDD
Arm Type
Active Comparator
Arm Description
1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Intervention Type
Device
Intervention Name(s)
Phase A - olifilcon B with Tangible Coatings
Intervention Description
Daily disposable silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Phase B - etafilcon A with Tangible Coatings
Intervention Description
Daily disposable hydrogel contact lens
Primary Outcome Measure Information:
Title
Subjective Lens Preference
Description
Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.
Time Frame
Visit 3 - Approximately 2 weeks
Secondary Outcome Measure Information:
Title
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
Description
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.
Time Frame
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L Chalmers, OD
Organizational Affiliation
Clinical Trial Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ross Eyecare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Professional Eye Care Center
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
RevolutionEyes
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Andover Optometry on Central
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Professional VisionCare
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Primary Eyecare Group, PC
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

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