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

Phase 3

Completed

• Conditions: Myopia
• Interventions: Drug: ClearCare; Drug: Optifree Replenish

• Registration Number: NCT00520351
• Lead Sponsor: University of Waterloo

Brief Summary

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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-24
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-03-26
• Status Verified: 2010-08
• Results First Submitted QC: 2010-08-20
• Last Update Submitted: 2010-08-20
• Results First Posted: 2010-09-16
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	ClearCare	-
2	Optifree Replenish	-

Primary Outcome Measures

Name	Time	Method
High Contrast Visual Acuity	2 weeks	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.
Low Contrast Visual Acuity	2 weeks	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.
In-vivo Wettability	2 weeks	Pre-lens non-invasive tear breakup time
Subjective Comfort Rating	2 weeks	Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.

Trial Locations

Locations (1)

Centre for Contact Lens Research, School of Optometry, University of Waterloo.; 🇨🇦 Waterloo, Ontario, Canada