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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094743
• Other study ID #: CR-1636AZ
• Status: Completed
• Phase: N/A
• Start date: February 1, 2010
• Est. completion date: March 1, 2010

Study information

• Verified date: September 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2010
• Est. primary completion date: March 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• galyfilcon A prototype lens
Silicone hydrogel contact lens
• lotrafilcon B lens
Silicon Hydrogel contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity Monocular	Snellen monocular visual acuity measurement	after 1 week of lens wear
Primary	Visual Acuity Binocular	Snellen binocular visual acuity measurement	after 1 week of lens wear
Primary	Subjective Assessment of Lens Comfort	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.	after 1 week of lens wear
Primary	Subjective Assessment of Quality of Vision	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.	after 1 week of lens wear
Secondary	Limbal Redness	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.	after 1 week of lens wear
Secondary	Bulbar Redness	Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.	after 1 week of lens wear
Secondary	Subjective Assessment of Lens Comfort	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.	10 minutes after lens insertion at time of initial lens fitting