Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

NCT00732004 | Completed

• 1 other identifier: H08 002
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.

Conditions

Myopia; Hyperopia

Study Arms (3)

1

EXPERIMENTAL

Group 1

Device: Silicone Hydrogel Contact Lenses

2

EXPERIMENTAL

Group 2

Device: 1x PMBH preserved MPS

3

EXPERIMENTAL

Group 3

Device: 1x Polyquad/Aldox MPS

Interventions

Silicone Hydrogel Contact Lenses DEVICE

1

1x PMBH preserved MPS DEVICE

2

1x Polyquad/Aldox MPS DEVICE

3

Eligibility Criteria

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

You may qualify if:

• Distance contact lens prescription between +8.00 and -10.00D.
• Cylindrical component of refractive error no greater than 1.25D in either eye.
• Vision correctable to 6/12 (0.30 logMAR) or better in each eye.
• Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.

You may not qualify if:

• Concurrent ocular medication
• Eye injury or surgery within twelve weeks immediately prior to enrolment.
• Current ocular irritation that would preclude contact lens fitting.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• Pregnant, lactating or planning a pregnancy.

Sponsors & Collaborators

• University of Melbourne: lead
• Clinical Vision Research Australia: collaborator
• Alcon Research: collaborator

Study Sites (1)

Clinical Vision Research Australia

Melbourne, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 11, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

AU (1)