Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
This study has been completed.
Sponsor:
University of Melbourne
Collaborators:
Clinical Vision Research Australia
Alcon Research
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00732004
First received: August 8, 2008
Last updated: June 30, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myopia Hyperopia |
Device: Silicone Hydrogel Contact Lenses Device: 1x PMBH preserved MPS Device: 1x Polyquad/Aldox MPS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
Resource links provided by NLM:
Further study details as provided by University of Melbourne:
| Estimated Enrollment: | 132 |
| Study Start Date: | August 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Group 1
|
Device: Silicone Hydrogel Contact Lenses |
|
Experimental: 2
Group 2
|
Device: 1x PMBH preserved MPS |
|
Experimental: 3
Group 3
|
Device: 1x Polyquad/Aldox MPS |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732004
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732004
Locations
| Australia, Victoria | |
| Clinical Vision Research Australia | |
| Melbourne, Victoria, Australia, 3053 | |
Sponsors and Collaborators
University of Melbourne
Clinical Vision Research Australia
Alcon Research
More Information
| Responsible Party: | Carol Lakkis, Clinical Vision Research Australia |
| ClinicalTrials.gov Identifier: | NCT00732004 History of Changes |
| Other Study ID Numbers: | H08 002 |
| Study First Received: | August 8, 2008 |
| Last Updated: | June 30, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Hyperopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on September 30, 2016