Clinical Performance Comparison of Two Contact Lenses

This study has been completed.

Sponsor:

Collaborator:

Visioncare Research Ltd.

Information provided by (Responsible Party):

Vistakon

ClinicalTrials.gov Identifier:

NCT00975585

First received: September 10, 2009

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Purpose

The purpose of this study is to compare the clinical performance of two contact lenses.

Condition	Intervention
Myopia	Device: senofilcon A Device: lotrafilcon B

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Average Corneal Staining [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Overall Comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Overall Comfort [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Secondary Outcome Measures:

Limbal Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Bulbar Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Symptoms of Dryness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None

Enrollment:	379
Study Start Date:	August 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: senofilcon A both eyes soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.	Device: senofilcon A soft contact lens, 2-week replacement indicated
Active Comparator: lotrafilcon B both eyes soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen	Device: lotrafilcon B soft contact lens with a 4-week replacement indicated.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Existing daily soft lens wearer.
Require a distance visual correction in both eyes.
Have a contact lens spherical distance refraction between -1.00D and -6.00D.
Have refractive astigmatism less than or equal to 1.00D in both eyes.
Achieve 20/30 or better corrected distance acuity.
Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

Requires presbyopic correction.
Requires ocular medications.
Grade 3 or 4 ocular abnormalities.
Grade 3 corneal staining in more than one region.
Has had refractive surgery.
Any other injury or ocular surgery within 8 weeks prior to study enrollment.
Has abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Has keratoconus or other corneal irregularity.
Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
Wears habitual contact lenses that are toric, multifocal or worn extended wear.
Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
Diabetic.
Infectious or immunosuppressive disease.
History of chronic eye disease (e.g glaucoma or age related macular degeneration).
Pregnancy, lactation or planning pregnancy at time of enrollment.
Participation in any concurrent clinical trial or in another trial in the last 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975585

Show 25 Study Locations

Sponsors and Collaborators

Vistakon

Visioncare Research Ltd.

Investigators

Study Director:

Sheila , B Hickson-Curran, BSc, MCOptom

Vistakon

More Information

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT00975585 History of Changes
Other Study ID Numbers:	CR-0907, PHNX-518
Study First Received:	September 10, 2009
Results First Received:	February 18, 2011
Last Updated:	October 6, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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