Clinical trial NCT04032457: PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Official title: PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lens
Lead sponsor: Vision Service Plan
Sponsor class: INDUSTRY
Collaborators: name: Foresight Regulatory Strategies, Inc.
First posted: 2019-07-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over after 1 week of wear of two lens brands.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective Lens Preference
timeFrame: Visit 3 - Approximately 2 weeks
Secondary outcomes:
measure: 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
timeFrame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Ross Eyecare
state: Georgia
city: Niles
country: United States
facility: Professional Eye Care Center
state: Illinois
city: Carmel
country: United States
facility: RevolutionEyes
state: Indiana
city: Andover
country: United States
facility: Andover Optometry on Central
state: Massachusetts
city: Westerville
country: United States
facility: Professional VisionCare
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, PC
state: Tennessee
Study officials:
affiliation: Clinical Trial Consultant
name: Robin L Chalmers, OD
role: PRINCIPAL_INVESTIGATOR
References: