Clinical Comparison of Two Daily Disposable Toric Lenses

NCT01362894 | Completed Results

• 1 other identifier: P-346-C-013
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (4)

• Overall Vision

  As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

  1 week, replacing lenses daily

• Overall Comfort

  As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.

  1 week, replacing lenses daily

• Overall Handling

  As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.

  1 week, replacing lenses daily

• Overall Satisfaction

  As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

  1 week, replacing lenses daily

Secondary Outcomes (1)

• Ease of Selecting Final Lens Power

  Day 0

Study Arms (2)

nelfilcon A / etafilcon A

OTHER

Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Device: nelfilcon A contact lens; Device: etafilcon A contact lens

etafilcon A / nelfilcon A

OTHER

Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Device: nelfilcon A contact lens; Device: etafilcon A contact lens

Interventions

nelfilcon A contact lens DEVICE

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.

Also known as: Focus® DAILIES® Toric

etafilcon A / nelfilcon A; nelfilcon A / etafilcon A

etafilcon A contact lens DEVICE

Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

Also known as: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM

etafilcon A / nelfilcon A; nelfilcon A / etafilcon A

Eligibility Criteria

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

You may qualify if:

• Sign written informed consent.
• Germany: Be of legal age.
• Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.

You may not qualify if:

• Eye injury or surgery within twelve weeks.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Wears contact lenses overnight while sleeping.
• Habitual daily disposable contact lens wearer.
• Monovision correction during the study.

Sponsors & Collaborators

• CIBA VISION: lead

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Stacie Cummings, O.D.
• Organization: Alcon Research, Ltd.

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 9, 2012
• Results First Posted: August 9, 2012

Record last verified: 2012-07