Pilot Dispensing Evaluation of a Plus Power Lens

Hyperopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228591
• Other study ID #: CR-1636BB
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: May 2015
• 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 the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• The subject must be at least 18 years of age and no more than 45 years of age.

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).

• The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.

• Any cylinder power must be = 0.75D.

• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

• The subject must read and sign the Statement of Informed Consent.

• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.

• Systemic disease or use of medication which might interfere with contact lens wear.

• 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.

• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Pregnancy or lactation.

• Diabetes.

• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

• Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.

• Need any near correction.

Related Conditions & MeSH terms

• Hyperopia

Intervention

Device:
• Acuvue Advance Plus
Silicone hydrogel contact lens.
• Acuvue Advance
Silicone 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 One Week After Lens Wear	Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.	1 week
Primary	Visual Acuity at Time of Initial Fit	Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.	After 10-15 minutes of lens wear
Secondary	Contact Lens Comfort Using Contact Lens User Experience (CLUE)	The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.	1 week
Secondary	Subject Reported Vision Using Contact Lens User Experience (CLUE).	Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.	1 week
Secondary	Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)	Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. CLUE scores have a range of 0-120.	Baseline
Secondary	Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)	Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.	Baseline