Clinical Performance Comparison of Two Contact Lenses

NCT00975585 | Completed Results

• 2 other identifiers: CR-0907PHNX-518
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Average Corneal Staining

  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.

  2 weeks

• Visual Acuity

  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.

  2 weeks

• Overall Comfort

  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.

  2 weeks

• Overall Comfort

  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.

  2 weeks and 4 weeks

Secondary Outcomes (3)

• Limbal Redness

  2 weeks

• Bulbar Redness

  2 weeks

• Symptoms of Dryness

  2 weeks

Study Arms (2)

senofilcon A both eyes

ACTIVE COMPARATOR

soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.

Device: senofilcon A

lotrafilcon B both eyes

ACTIVE COMPARATOR

soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

Device: lotrafilcon B

Interventions

senofilcon A DEVICE

soft contact lens, 2-week replacement indicated

senofilcon A both eyes

lotrafilcon B DEVICE

soft contact lens with a 4-week replacement indicated.

lotrafilcon B both eyes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (25)

Unknown Facility

North Little Rock, Arkansas, 72116, United States

Location

Unknown Facility

Campbell, California, 95008, United States

Location

Unknown Facility

Colorado Springs, Colorado, 80909, United States

Location

Unknown Facility

Jacksonville, Florida, 32205, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Miami, Florida, 33155, United States

Location

Unknown Facility

Winter Park, Florida, 32792, United States

Location

Unknown Facility

Roswell, Georgia, 30076, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Cambridge, Massachusetts, 02140, United States

Location

Unknown Facility

Blue Springs, Missouri, 64015, United States

Location

Unknown Facility

New York, New York, 10001, United States

Location

Unknown Facility

Chagrin Falls, Ohio, 44023, United States

Location

Unknown Facility

North Olmsted, Ohio, 44070, United States

Location

Unknown Facility

Warren, Ohio, 44484, United States

Location

Unknown Facility

State College, Pennsylvania, 16801, United States

Location

Unknown Facility

Warwick, Rhode Island, 02888, United States

Location

Unknown Facility

Chamberlain, South Dakota, 57325, United States

Location

Unknown Facility

Hot Springs, South Dakota, 57747, United States

Location

Unknown Facility

Bartlett, Tennessee, 38134, United States

Location

Unknown Facility

Brentwood, Tennessee, 37027, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

Tyler, Texas, 757703, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sheila Hickson-Curran, MCOptom/ Director, Medical Affairs
• Organization: Vistakon

904-443-1754

Study Officials

• Sheila, B Hickson-Curran, BSc, MCOptom

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 19, 2018
• Results First Posted: March 22, 2011

Record last verified: 2017-08

Locations

US (25)