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Clinical Trials/NCT00732004
NCT00732004CompletedNot Applicable

Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

University of Melbourne1 site in 1 country132 target enrollmentStarted: August 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

1

Experimental

Group 1

Intervention: Silicone Hydrogel Contact Lenses (Device)

2

Experimental

Group 2

Intervention: 1x PMBH preserved MPS (Device)

3

Experimental

Group 3

Intervention: 1x Polyquad/Aldox MPS (Device)

Investigators

Sponsor Class
Other

Study Sites (1)

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