Back to resultsMulti-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nelfilcon A contact lens
UltraFilcon B contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error focused on measuring contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted
Eligibility Criteria
Inclusion Criteria:
- 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;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- 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;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Visioncare Research Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Nelfilcon A/UltraFilcon B
UltraFilcon B/Nelfilcon A
Arm Description
Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
End of Day Comfort
End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Overall Comfort
Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Overall Handling at Time of Removal
Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01917162
Brief Title
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)
Official Title
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
contact lenses, daily disposable contact lenses, silicone hydrogel, contact lens comfort, near-sighted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nelfilcon A/UltraFilcon B
Arm Type
Other
Arm Description
Nelfilcon A contact lenses, followed by UltraFilcon B contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Arm Title
UltraFilcon B/Nelfilcon A
Arm Type
Other
Arm Description
UltraFilcon B contact lenses, followed by Nelfilcon A contact lenses. Each product worn bilaterally for one week in a daily wear, daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
Soft contact lens CE-marked for daily disposable wear.
Intervention Type
Device
Intervention Name(s)
UltraFilcon B contact lens
Other Intervention Name(s)
Procornea BYO Air Daily
Intervention Description
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Primary Outcome Measure Information:
Title
Initial comfort
Description
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).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
End of Day Comfort
Description
End of Day Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. End of Day Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Time Frame
Day 7
Title
Overall Comfort
Description
Overall Comfort will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
Time Frame
Day 7
Title
Overall Handling at Time of Removal
Description
Overall Handling at Time of Removal will be assessed by the participant as a retrospective, bilateral evaluation of 1 week of wear. Overall Handling at Time of Removal will be graded on a 1-10 scale (10=excellent, very easy; 1=unmanageable).
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Nick, Dipl. Ing.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Visioncare Research Ltd
City
Farnham
State/Province
Surrey
ZIP/Postal Code
GU9 7EN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses (Study 2)
We'll reach out to this number within 24 hrs