PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Vision Service Plan

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Phase A - olifilcon B with Tangible Coatings; Device: Phase B - etafilcon A with Tangible Coatings

Study type: Interventional

Funder types: Industry

Identifiers

NCT04032457

VS-19-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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144 participants in 12 patient groups

A1 - SiHyDD to Moist

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

A2 - Moist to SiHyDD

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

A3 - SiHyDD to OASDD

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

A4 - OASDD to SiHyDD

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

A5 - SiHyDD to DT1

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

A6 - DT1 to SiHyDD

Active Comparator group

Description:

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

Treatment:

Device: Phase A - olifilcon B with Tangible Coatings

B1 - HydDD to Moist

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings

B2 - Moist to HydDD

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings

B3 - HydDD to BioTrue

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings

B4 - BioTrue to HydDD

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings

B5 - HydDD to AqCom+

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings

B6 - AqCom+ to HydDD

Active Comparator group

Description:

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

Treatment:

Device: Phase B - etafilcon A with Tangible Coatings