Official Title

Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    acetaminophen ...
  • Study Participants

    30
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings
Study Started
Aug 31
2007
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Results Posted
Sep 16
2010
Estimate
Last Update
Sep 16
2010
Estimate

Drug ClearCare

contact lens care system

Drug Optifree Replenish

contact lens care system

1 Active Comparator

2 Active Comparator

Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

Is at least 17 years of age and has full legal capacity to volunteer.
Has read, understood and signed an information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is presently using either bi-weekly or monthly replacement lenses.
Has symptoms of ocular dryness as determined by specific pre-screening criteria.
Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
Has clear corneas and no active ocular disease.
Has had an ocular examination in the last two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

Is an asymptomatic lens wearer.
Is a daily disposable contact lens wearer.
Is a current extended wear contact lens wearer.
Currently uses one of the study lens care regimens.
Has any clinically significant blepharitis.
Has undergone corneal refractive surgery.
Is aphakic.
Has any active ocular disease.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that may affect ocular health.
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Is participating in any other type of clinical or research study.

Summary

ClearCare First, Then Optifree Replenish

Optifree Replenish First, Then ClearCare

All Events

Event Type Organ System Event Term

High Contrast Visual Acuity

High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.

ClearCare First, Then Optifree Replenish

-0.04
logMAR (Mean)
Standard Deviation: 0.06

Optifree Replenish First, Then ClearCare

-0.04
logMAR (Mean)
Standard Deviation: 0.06

Low Contrast Visual Acuity

Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.

ClearCare First, Then Optifree Replenish

0.26
logMAR (Mean)
Standard Deviation: 0.07

Optifree Replenish First, Then ClearCare

0.25
logMAR (Mean)
Standard Deviation: 0.08

In-vivo Wettability

Pre-lens non-invasive tear breakup time

ClearCare First, Then Optifree Replenish

7.06
Seconds (Least Squares Mean)
95% Confidence Interval: 5.8 to 8.3

Optifree Replenish First, Then ClearCare

6.54
Seconds (Least Squares Mean)
95% Confidence Interval: 5.7 to 7.4

Subjective Comfort Rating

Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.

ClearCare First, Then Optifree Replenish

82.5
Units on a scale (Mean)
95% Confidence Interval: 70.3 to 94.8

Optifree Replenish First, Then ClearCare

81.3
Units on a scale (Mean)
95% Confidence Interval: 64.9 to 97.8

Total

30
Participants

Age Continuous

24.3
years (Mean)
Standard Deviation: 5.1

Age, Categorical

Region of Enrollment

Sex: Female, Male

First Intervention

ClearCare First, Then Optifree Replenish

Optifree Replenish First, Then ClearCare

Second Intervention

ClearCare First, Then Optifree Replenish

Optifree Replenish First, Then ClearCare

Drop/Withdrawal Reasons

ClearCare First, Then Optifree Replenish

Optifree Replenish First, Then ClearCare