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

Purpose

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.

Condition	Intervention
Myopia	Device: Delefilcon A contact lens Device: Etafilcon A contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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 Outcome Measures:

Overall Lens Fit [ Time Frame: 1 week of wear, replacing lenses daily ] [ Designated as safety issue: No ]
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.

Enrollment:	40
Study Start Date:	May 2011
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Delefilcon A / etafilcon A Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear Other Name: DAILIES® Total1® Device: Etafilcon A contact lens Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear Other Name: 1-DAY ACUVUE® MOIST™
Etafilcon A / delefilcon A Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Device: Delefilcon A contact lens Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear Other Name: DAILIES® Total1® Device: Etafilcon A contact lens Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear Other Name: 1-DAY ACUVUE® MOIST™

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 exclusion criteria may apply.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01362907 History of Changes
Other Study ID Numbers:	P-347-C-013
Study First Received:	May 27, 2011
Results First Received:	June 28, 2012
Last Updated:	June 28, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013