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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520351
• Other study ID #: P/265/07/L
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2007
• Last updated: August 20, 2010
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2010
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• ClearCare
contact lens care system
• Optifree Replenish
contact lens care system

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, School of Optometry, University of Waterloo.	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	In-vivo Wettability	Pre-lens non-invasive tear breakup time	2 weeks	No
Primary	Subjective Comfort Rating	Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.	2 weeks	No