Clinical Trial: Performance of a Multifocal Contact Lens - Presbyopia Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.

Detailed Summary:
Sponsor: Johnson & Johnson Vision Care, Inc.

Current Primary Outcome:

• The Total Grade of Conjunctival Hyperemia [ Time Frame: Baseline to 4-Week Follow-up ]
  Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia
• Upper Lid Margin Staining Score [ Time Frame: Baseline to 4-Week Follow-up ]
  Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.
• Average Corneal Staining Area Grade [ Time Frame: Baseline to 4- Week Follow-up ]
  Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.

Original Primary Outcome:

• Conjunctival Hyperemia [ Time Frame: Measured 30 days post baseline ]
  Hyperemia will be measured on a scale from 0 - 4, 0 = no findings; 4 = severe reddness
• Upper Lid Margin Staining [ Time Frame: Measured 30 days post baseline ]
  Upper Lid Margin Staining will be measured on a 0.0 to 4.0 grading scale; with 0 being no staining and 4.0 being severe staining.
• Corneal Staining [ Time Frame: Measured 30 days post baseline ]
  Corneal staining will be measured using a 0 - 4 grading scale; 0 = normal cornea, 4 = Severe Staining

Current Secondary Outcome:

Original Secondary Outcome: Corneal Thickness [ Time Frame: Measured 30 days post baseline ]

Dates:
Date Received: April 17, 2015
Date Started: April 2015
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016