Clinical Evaluation of an Investigational Soft Contact Lens

NCT01254747 | Completed Results

• 1 other identifier: P-347-C-003v2s2v2
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

• Overall Comfort

  Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  4 weeks

• Vision Quality During the Day

  Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  4 weeks

• Overall Handling

  Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.

  4 weeks

• Dryness Throughout the Day

  Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

  4 weeks

• Average Daily Wear Time

  Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.

  4 weeks

Secondary Outcomes (3)

• Lens Fit

  4 weeks

• Corrected Visual Acuity

  4 weeks

• Overall Satisfaction

  4 weeks

Study Arms (4)

Delefilcon A

EXPERIMENTAL

Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Device: Delefilcon A contact lens

Lotrafilcon B

ACTIVE COMPARATOR

Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)

Nelfilcon A

ACTIVE COMPARATOR

Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Narafilcon A

ACTIVE COMPARATOR

Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)

Interventions

Delefilcon A contact lens DEVICE

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

Also known as: DAILIES TOTAL1®

Delefilcon A

Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX) DEVICE

Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Also known as: O2 OPTIX®, AIR OPTIX®

Lotrafilcon B

Nelfilcon A contact lens (DAILIES AquaComfort Plus) DEVICE

Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use

Also known as: DAILIES® AquaComfort Plus®

Nelfilcon A

Narafilcon A contact lens (1-DAY ACUVUE TRUEYE) DEVICE

Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Also known as: 1-DAY ACUVUE® TRUEYE™

Narafilcon A

Eligibility Criteria

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

You may qualify if:

• Germany: Be of legal age.
• USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
• Sign Informed Consent.
• Wear soft contact lenses for at least 3 months prior to the study.
• Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.

You may not qualify if:

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Regularly wear contact lenses on an extended/overnight basis.
• Germany: pregnant or lactating.

Sponsors & Collaborators

• CIBA VISION: lead

Study Sites (2)

CIBA VISION Research Clinic

Duluth, Georgia, 30097, United States

Location

CIBA VISION Research Clinic

Großwallstadt, 63868, Germany

Location

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: 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: December 3, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 10, 2012
• Results First Posted: May 17, 2012

Record last verified: 2012-04

Locations

US (1); DE (1)