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

Refractive Error Clinical Trial

Official title:

Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917162
• Other study ID #: C-13-033
• Status: Completed
• Phase: N/A
• First received: August 4, 2013
• Last updated: November 6, 2013
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A contact lens
Soft contact lens CE-marked for daily disposable wear.
• UltraFilcon B contact lens
Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.

Locations

Country	Name	City	State
United Kingdom	Visioncare Research Ltd	Farnham	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	Day 7	No
Secondary	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).	Day 7	No
Secondary	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).	Day 7	No