Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Ametropia Clinical Trial

Official title:

Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754338
• Other study ID #: P/279/07/L
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2023
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Description:

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• 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 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.

• Is a current soft lens wearer, replacing their lenses every two weeks to one month.

• Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.

• Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

• Has any signs or symptoms of dry eye.

• 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 pregnant or lactating.

• Is participating in any other type of clinical or research study.

• Currently wears daily disposable lenses.

• Currently wears lenses on an extended wear basis.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Drug:
• Alcon Opti-Free® RepleniSH® with Supraclens®
Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
• Alcon Opti-Free® RepleniSH®
Marketed Multipurpose Disinfecting Care System
• B&L ReNu MultiPlus™
Marketed Multipurpose Disinfecting Care Systems

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	Comfort	Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.	4 weeks
Primary	Lens Wettability	Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).	4 weeks
Primary	Lens Deposits	Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).	4 weeks
Secondary	Dryness	Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.	4 weeks
Secondary	Subjective Vision	Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.	4 weeks
Secondary	Corneal Staining	Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.; Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.; A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.	4 weeks