Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: galyfilcon A prototype lens; Device: lotrafilcon B lens

• Registration Number: NCT01094743
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Primary Completion: 2010-03-01
• Study Completion: 2010-03-01
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-29
• Results First Submitted: 2011-11-07
• Results First Submitted QC: 2011-12-19
• Results First Posted: 2012-01-25
• Status Verified: 2017-09
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. The subject must be at least 18 years of age and no more than 39 years of age.
2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
4. Any cylinder power must be ≤ -0.75D.
5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
6. The subject must read and sign the Statement of Informed Consent.
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
2. Systemic disease or use of medication which might interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Pregnancy or lactation.
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
10. Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
galyfilcon A prototype lens / lotrafilcon B lens	lotrafilcon B lens	The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
lotrafilcon B lens / galyfilcon A prototype lens	galyfilcon A prototype lens	The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
galyfilcon A prototype lens / lotrafilcon B lens	galyfilcon A prototype lens	The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
lotrafilcon B lens / galyfilcon A prototype lens	lotrafilcon B lens	The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.

Primary Outcome Measures

Name	Time	Method
Subjective Assessment of Quality of Vision	after 1 week of lens wear	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Visual Acuity Monocular	after 1 week of lens wear	Snellen monocular visual acuity measurement
Visual Acuity Binocular	after 1 week of lens wear	Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort	after 1 week of lens wear	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Secondary Outcome Measures

Name	Time	Method
Limbal Redness	after 1 week of lens wear	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Bulbar Redness	after 1 week of lens wear	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Subjective Assessment of Lens Comfort	10 minutes after lens insertion at time of initial lens fitting	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.