Clinical trial NCT03360110: Comparison of New Contact Lens With Current Marketed Lens
Official title: Clinical Validation Study of Phoebe Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-12-02
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate the clinical performance of a new contact lens design.

Detailed description: Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Eligibility criteria: Inclusion criteria

A person is eligible for inclusion in the study if he/she:

* Between and 18 and 35 years of age and has full legal capacity to volunteer
* Has had a self-reported oculo-visual examination in the last two years
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
* Has a Contact Lens Refraction between -1.00D and -6.00D
* Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
* Currently wears soft contact lenses
* Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
* Has clear corneas and no active ocular disease
* Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Is wearing Monovision modality
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars
* Is aphakic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study

Primary outcomes:
measure: Corneal Staining Extent
timeFrame: Baseline
measure: Corneal Staining Extent
timeFrame: Day 3
measure: Conjunctival Staining Score
timeFrame: Baseline
measure: Conjunctival Staining Score
timeFrame: Day 3
measure: Palpebral Hyperemia on Upper Lid
timeFrame: Baseline
measure: Palpebral Hyperemia on Upper Lid
timeFrame: Day 3
measure: Palpebral Hyperemia on Lower Lid
timeFrame: Baseline
measure: Palpebral Hyperemia on Lower Lid
timeFrame: Day 3
measure: Palpebral Roughness Grade - Upper Lid
timeFrame: Baseline
measure: Palpebral Roughness Grade - Upper Lid
timeFrame: Day 3
measure: Palpebral Roughness Grade - Lower Lid
timeFrame: Baseline
measure: Palpebral Roughness Grade - Lower Lid
timeFrame: Day 3
Secondary outcomes:
measure: Distance Visual Acuity
timeFrame: Baseline (at lens dispense)
measure: Distance Visual Acuity
timeFrame: Day 3
measure: Near Visual Acuity
timeFrame: Baseline (at dispense)
measure: Near Visual Acuity
timeFrame: Day 3
measure: Vision Quality Rating
timeFrame: Baseline (at dispense)
measure: Vision Quality Rating
timeFrame: Day 3
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optical Research Lab (CORL)
state: Indiana
Study officials:
affiliation: Clinical Optics Research Lab (CORL), Indiana University
name: Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA
role: PRINCIPAL_INVESTIGATOR
References: