Clinical trial NCT00754338: Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Official title: Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Keywords: comfort
wetability
protein deposit
lipid deposit
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-09-18
Enrollment: 76
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort
timeFrame: 4 weeks
measure: Lens Wettability
timeFrame: 4 weeks
measure: Lens Deposits
timeFrame: 4 weeks
Secondary outcomes:
measure: Dryness
timeFrame: 4 weeks
measure: Subjective Vision
timeFrame: 4 weeks
measure: Corneal Staining
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, School of Optometry, University of Waterloo.
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Desmond Fonn, MOptom
role: STUDY_CHAIR
References: