Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

NCT00349843 | Completed Phase 4

• 1 other identifier: P/211/04/L
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• The primary objective of this study is to compare corneal staining over time in

• a group of individuals who wear soft contact lenses on a daily wear basis,

• whilst they sequentially use two different contact lens care regimens.

Secondary Outcomes (3)

• The secondary objective of this study is to compare subjective ocular symptoms

• over time in a group of individuals who wear soft contact lenses on a daily wear

• basis, whilst they sequentially use two different contact lens care regimens.

Interventions

Soft contact lens DEVICE

Marketed soft lens multipurpose disinfection regimen DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
• Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
• Is correctable to a visual acuity of 6/6 or better with their habitual correction.
• Is willing and able to follow product usage instructions and maintain the visit schedule.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Can be successfully fitted with study lens type.
• Has read, understood and signed an Information Consent Letter.
• Has a distance contact lens prescription is between -0.50 D and -9.00 D
• Has astigmatism of ≤ 1.00 D Cyl
• Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
• Has no systemic disease affecting ocular health.
• Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
• Has clear corneas and no active ocular disease.
• Has no known ocular or systemic allergies, which could interfere with contact lens wear.
• Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.

You may not qualify if:

• Has any active ocular disease.
• Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
• Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
• Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
• Is using topical ocular prescription or any topical over-the-counter medication.
• Is actively involved in any other research/clinical study.
• Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
• Has had corneal refractive surgery.
• Has known sensitivity to any of the study solutions.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Craig Woods, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Desmond Fonn, MOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: June 1, 2005
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)