Clinical Evaluation of an Investigational Soft Contact Lens
This study has been completed.
Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01254747
First received: December 3, 2010
Last updated: June 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Delefilcon A contact lens Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX) Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus) Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Overall Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Vision Quality During the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Overall Handling [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Dryness Throughout the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Average Daily Wear Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Secondary Outcome Measures:
- Lens Fit [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Corrected Visual Acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Overall Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 130 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
|
Device: Delefilcon A contact lens
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: DAILIES TOTAL1®
|
|
Active Comparator: Lotrafilcon B
Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
|
Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Names:
|
|
Active Comparator: Nelfilcon A
Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
|
Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®
|
|
Active Comparator: Narafilcon A
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
|
Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE® TRUEYE™
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT01254747 History of Changes |
| Other Study ID Numbers: | P-347-C-003v2s2v2 |
| Study First Received: | December 3, 2010 |
| Results First Received: | April 18, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013