Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)

NCT01917162 | Completed

• 1 other identifier: C-13-033
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.

Conditions

Refractive Error

Keywords

contact lenses; daily disposable contact lenses; silicone hydrogel; contact lens comfort; near-sighted

Outcome Measures

Primary Outcomes (1)

• Initial comfort

  Initial Comfort (within 10-15 minutes of lens insertion) will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).

  Baseline

Secondary Outcomes (3)

• End of Day Comfort

  Day 7

• Overall Comfort

  Day 7

• Overall Handling at Time of Removal

  Day 7

Study Arms (2)

Nelfilcon A/UltraFilcon B

OTHER

Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens

UltraFilcon B/Nelfilcon A

OTHER

UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.

Device: Nelfilcon A contact lens; Device: UltraFilcon B contact lens

Interventions

Nelfilcon A contact lens DEVICE

Soft contact lens CE-marked for daily disposable wear.

Also known as: DAILIES® AquaComfort Plus®

Nelfilcon A/UltraFilcon B; UltraFilcon B/Nelfilcon A

UltraFilcon B contact lens DEVICE

Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Also known as: Procornea BYO Air Daily

Nelfilcon A/UltraFilcon B; UltraFilcon B/Nelfilcon A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adapted soft contact lens wearer;
• Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
• Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
• Correctable to 6/9 (20/30) in both eyes;
• Read, understand, and sign the informed consent;
• Willing to comply with the wear schedule;
• Willing to comply with the study visit schedule;

You may not qualify if:

• Any active corneal infection, injury or inflammation;
• Systemic or ocular allergies which might interfere with contact lens wear;
• Systemic or ocular disease which might interfere with contact lens wear;
• Strabismus or amblyopia;
• Corneal refractive surgery and any anterior segment surgery;
• Use of systemic/topical medication contraindicating contact lens wear;
• Use of gas permeable contact lenses within 1 month preceding the study;
• Participation in any concurrent clinical trial or in the last 30 days;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Visioncare Research Ltd

Farnham, Surrey, GU9 7EN, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Joachim Nick, Dipl. Ing.

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

GB (1)