Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

NCT01898260 | Completed

• 1 other identifier: C-13-032
• Study Type: interventional
• Target: 89
• 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

Myopia; 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 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)

BYO Daily, then MyDay

OTHER

Ultrafilcon B contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.

Device: Ultrafilcon B contact lens; Device: Stenfilcon A contact lens

MyDay, then BYO Daily

OTHER

Stenfilcon A contact lenses, followed by ultrafilcon B contact lenses. Each product worn bilaterally for 1 week in a daily wear, daily disposable modality.

Device: Ultrafilcon B contact lens; Device: Stenfilcon A contact lens

Interventions

Ultrafilcon B contact lens DEVICE

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

Also known as: Procornea BYO™ Air Daily

BYO Daily, then MyDay; MyDay, then BYO Daily

Stenfilcon A contact lens DEVICE

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

Also known as: MyDay™ Daily Disposable

BYO Daily, then MyDay; MyDay, then BYO Daily

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, understood and signed 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)

Alcon Investigative Site

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

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

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 12, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 12, 2015

Record last verified: 2014-10

Locations

GB (1)