Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01362907

Enrollment

Registered

2011-06-01

Start date

2011-05-31

Completion date

2011-06-30

Last updated

2012-08-03

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 trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Interventions

DEVICEDelefilcon A contact lens

Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear

DEVICEEtafilcon A contact lens

Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Normal eyes with no use of ocular medications. * Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. * Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps). * Visual acuity with study lenses 20/25 or better. * Cylinder less than or equal to 0.75 D. * Currently wearing daily disposable lenses. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Anterior segment infection, inflammation, or abnormality. * Any active anterior segment ocular disease that would contraindicate contact lens wear. * Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * History of refractive surgery or irregular cornea. * Eye injury within twelve weeks immediately prior to enrollment for this trial. * Currently enrolled in any clinical trial. * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)	1 week of wear, replacing lenses daily	As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Overall Comfort	1 week of wear, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Vision Quality	1 week of wear, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling	1 week of wear, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

Secondary

Measure	Time frame	Description
Overall Lens Fit	1 week of wear, replacing lenses daily	As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.

Participant flow

Recruitment details

Participants were recruited from 4 US private practices.

Participants by arm

Arm	Count
Overall All enrolled participants	40
Total	40

Baseline characteristics

Characteristic	Overall
Age Continuous	32.7 years STANDARD_DEVIATION 9.5
Region of Enrollment United States	40 participants
Sex: Female, Male Female	29 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 40	0 / 40
serious Total, serious adverse events	0 / 40	0 / 40

Outcome results

Primary

Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)

As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.