Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

NCT00953407 | Completed Results

• 1 other identifier: P-337-C-027
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Lens Awareness

  Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.

  4 weeks of wear

Study Arms (5)

Nelfilcon A

EXPERIMENTAL

Nelfilcon A contact lens

Device: Nelfilcon A contact lens

Narafilcon A

ACTIVE COMPARATOR

Narafilcon A contact lens

Device: Narafilcon A contact lens

Etafilcon A

ACTIVE COMPARATOR

Etafilcon A contact lens

Device: Etafilcon A contact lens

Omafilcon A

ACTIVE COMPARATOR

Omafilcon A contact lens

Device: Omafilcon A contact lens

Hilafilcon B

ACTIVE COMPARATOR

Hilafilcon B contact lens

Device: Hilafilcon B contact lens

Interventions

Nelfilcon A contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Nelfilcon A

Narafilcon A contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Narafilcon A

Etafilcon A contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Etafilcon A

Omafilcon A contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Omafilcon A

Hilafilcon B contact lens DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Hilafilcon B

Eligibility Criteria

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

You may qualify if:

• Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
• Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
• Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
• Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.

You may not qualify if:

• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of corneal refractive surgery.
• Cylinder correction greater than 1.00 D.
• Current monovision contact lens wearers.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
• Organization: CIBA VISION

priya.janakiraman@cibavision.com

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: August 6, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 10, 2012
• Results First Posted: November 1, 2010

Record last verified: 2012-01