Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02920957

Enrollment

Registered

2016-09-30

Start date

2016-09-30

Completion date

2016-11-23

Last updated

2018-01-09

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

Conditions

Myopia

Brief summary

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Detailed description

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Interventions

DEVICEcomfilcon A

contact lens

DEVICEsenofilcon C

contact lens

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 34 Years

Healthy volunteers

Yes

Inclusion criteria

A person is eligible for inclusion in the study if he/she: * Is between 18 and 34 years of age (inclusive) * Has had a self-reported eye exam in the last two years * Is a spherical soft contact lens wearer * Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive) * Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Has a contact lens prescription that fits within the available parameters of the study lenses. * Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule

Exclusion criteria

A person will be excluded from the study if he/she: * Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; \> 10 hours/day) * Presents with clinically significant anterior segment abnormalities * Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear. * Presents with slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Significant pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (or history in past year) * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study. * Is habitually using rewetting/ lubricating eye drops more than once per day * Is currently wearing daily disposable lenses

Design outcomes

Primary

Measure	Time frame	Description
Overall Lens Fit Acceptance	Up to 1 month	Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Corneal Coverage	Up to 1 month	Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Lens Centration	Up to 1 month	Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Tightness on Push up	Up to 1 month	Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Post-blink Movement	Up to 1 month	Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Lens Lag at Primary Gaze	Up to 1 month	Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Lens Wettability	Up to 1 month	Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Deposit Grading	Up to 1 month	Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)

Countries

United States

Participant flow

Pre-assignment details

There were 88 participants enrolled for this study, with 1 participant failed the screening leading to 87 who were fitted with and dispensed contact lenses.

Participants by arm

Arm	Count
Overall Baseline Characteristics Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first.	87
Total	87

Withdrawals & dropouts

Period	Reason	FG000	FG001
First Intervention : 1 Month	Adverse Event	1	0
First Intervention : 1 Month	Lost to Follow-up	1	0
First Intervention : 1 Month	Withdrawal by Subject	2	0
Second Intervention: 1 Month	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Overall Baseline Characteristics
Age, Continuous Age	27.9 years STANDARD_DEVIATION 4.3
Sex: Female, Male Female	50 Participants
Sex: Female, Male Male	37 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 87	0 / 83
serious Total, serious adverse events	1 / 87	0 / 83

Outcome results

Primary