Comparison of Three Soft Bifocal Contact Lenses

Presbyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808340
• Other study ID #: CR-1485FA
• Status: Completed
• Phase: N/A
• Start date: November 1, 2008
• Est. completion date: December 1, 2008

Study information

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

Clinical Trial Summary

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 1, 2008
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• The subject must between 35 and 70 years of age.

• The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).

• The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.

• Refractive cylinder must be less than or equal to -0.75 D in each eye.

• The subject must have an add power of +0.75D to +2.50D in each eye.

• The subject must have best corrected visual acuity of 20/20-3 or better in each eye.

• The subject's must have at least 20/30-distance vision with the study contact lenses.

• The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses.

• The subject must be an adapted soft contact lens wearer in both eyes.

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

• The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria:

• Ocular or systemic allergies or disease that may interfere with contact lens wear.

• Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.

• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.

• Clinically significant (grade 3 or 4) tarsal abnormalities that 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

• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).

• History of diabetes. History of binocular vision abnormality or strabismus.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• balafilcon A
multifocal contact lens
• senofilcon A production
multifocal contact lens
• senofilcon A test
multifocal 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	Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity	Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	5 minutes after insertion
Primary	Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity	Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	5 minutes after insertion
Primary	Type of Corneal Staining	Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).	after 1 week of lens wear, for each lens type
Primary	Overall Subjective Vision	Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	after 1 week of lens wear, for each lens type