Clinical Evaluation of an Investigational Soft Contact Lens

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254747
• Other study ID #: P-347-C-003v2s2v2
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: June 26, 2012
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• 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.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lens
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
• Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
• Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
• Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use

Locations

Country	Name	City	State
Germany	CIBA VISION Research Clinic	Grosswallstadt
United States	CIBA VISION Research Clinic	Duluth	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Lens Fit	Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.	4 weeks	No
Secondary	Corrected Visual Acuity	Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.	4 weeks	No
Secondary	Overall Satisfaction	Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.	4 weeks	No