Comparison of New Contact Lens With Current Marketed Lens

Clinical Validation Study of Phoebe Lens

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03360110

Enrollment

Registered

2017-12-02

Start date

2017-11-06

Completion date

2017-12-15

Last updated

2020-09-02

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

Conditions

Myopia

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).

Interventions

DEVICEPhoebe test lens

Daily disposable contact lens

DEVICEstenfilcon A lens (control)

Daily disposable contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double masked (participant, investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Palpebral Roughness Grade - Lower Lid	Baseline	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Hyperemia on Upper Lid	Baseline	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid	Baseline	Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid	Baseline	Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Corneal Staining Extent	Baseline	Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Conjunctival Staining Score	Baseline	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps

Secondary

Measure	Time frame	Description
Near Visual Acuity	Baseline (at dispense)	Near visual acuity recorded in logMAR
Vision Quality Rating	Baseline (at dispense)	Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Distance Visual Acuity	Baseline (at lens dispense)	Distance visual acuity recorded in logMAR.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Overall Study Subjects randomized to wear pair of test/control lens either first or second, then wear other lens. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens	47
Total	47

Baseline characteristics

Characteristic	Overall Study
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	47 Participants
Age, Continuous	23 years STANDARD_DEVIATION 3
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	47 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	47 participants
Sex: Female, Male Female	35 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 53
other Total, other adverse events	0 / 53	0 / 53
serious Total, serious adverse events	0 / 53	0 / 53

Outcome results

Primary