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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: ClearCare; Drug: Optifree Replenish

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: Optifree Replenish; contact lens care system
Active Comparator: 1	Drug: ClearCare; contact lens care system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	2 weeks
In-vivo Wettability	Pre-lens non-invasive tear breakup time	2 weeks
Subjective Comfort Rating	Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.	2 weeks

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Desmond Fonn, M. Optom, University of Waterloo

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 21, 2007
• First Submitted That Met QC Criteria: August 23, 2007
• First Posted (Estimate): August 24, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2010
• Last Update Submitted That Met QC Criteria: August 20, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P/265/07/L