Prospective Study of an Investigational Daily Disposable Contact Lens

NCT01295905 | Completed Results

• 1 other identifier: P-347-C-004
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity

  Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

  3 months of wear, lenses replaced daily

Secondary Outcomes (3)

• Overall Vision

  3 months of wear, lenses replaced daily

• Overall Comfort

  3 months of wear, lenses replaced daily

• Overall Handling

  3 months of wear, lenses replaced daily

Study Arms (2)

delefilcon A

EXPERIMENTAL

Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Device: delefilcon A contact lens

narafilcon B

ACTIVE COMPARATOR

Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.

Device: narafilcon B contact lens

Interventions

delefilcon A contact lens DEVICE

Investigational silicone hydrogel, single vision soft contact lens

delefilcon A

narafilcon B contact lens DEVICE

Commercially marketed silicone hydrogel, single vision soft contact lens

narafilcon B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with normal eyes who are not using any 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 at least 5 days per week.
• Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
• Best spectacle-corrected visual acuity greater than or equal to 20/25.
• Manifest cylinder less than or equal to 0.75D.

You may not qualify if:

• 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.
• History of pathologically dry eye.
• Eye injury within twelve weeks immediately prior to enrollment for this trial.
• Currently enrolled in any clinical trial.
• Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Alcon Clinical, Atlanta
• Organization: Alcon Research

1-800-241-7629

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 10, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-05