Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

University of Melbourne

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: 1x PMBH preserved MPS; Device: Silicone Hydrogel Contact Lenses; Device: 1x Polyquad/Aldox MPS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00732004

H08 002

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 3 patient groups

1

Experimental group

Description:

Group 1

Treatment:

Device: Silicone Hydrogel Contact Lenses

2

Experimental group

Description:

Group 2

Treatment:

Device: 1x PMBH preserved MPS

3

Experimental group

Description:

Group 3

Treatment:

Device: 1x Polyquad/Aldox MPS