PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04032457

Acronym

PAVES

Enrollment

144

Registered

2019-07-25

Start date

2019-03-15

Completion date

2019-08-02

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Errors

Keywords

Contact Lens

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.

Interventions

DEVICEPhase A - olifilcon B with Tangible Coatings

Daily disposable silicone hydrogel contact lens

DEVICEPhase B - etafilcon A with Tangible Coatings

Daily disposable hydrogel contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 42 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Subjective Lens Preference	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

Measure	Time frame	Description
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026