Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732004
• Other study ID #: H08 002
• Status: Completed
• Phase: N/A
• First received: August 8, 2008
• Last updated: June 30, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Silicone Hydrogel Contact Lenses

• 1x PMBH preserved MPS

• 1x Polyquad/Aldox MPS

Locations

Country	Name	City	State
Australia	Clinical Vision Research Australia	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
University of Melbourne	Alcon Research, Clinical Vision Research Australia

Country where clinical trial is conducted

Australia,