Dry Eye SyndromesNCT00372034
The Effect of Punctal Plugs on Tear Volume and Osmolality
A study testing Temporary Collagen Inserts in people with Dry Eye Syndromes, run by The University of New South Wales at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Temporary Collagen Inserts
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years of age
Who cannot join
- Corneal refractive surgery
- Contraindications to contact lens wear
- Latex allergy
- Corneal hypoesthesia
- Active corneal infection
- Acute or sub-acute inflammation or infection of the anterior chamber of the eye
Trial locations and contacts
1 site in 1 country.
Australia1 site
Vision CRC, Institute for Eye Research, School of Optometry and Vision Science
Sydney, New South Wales, 2033
About this study
The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.
Read the detailed description
50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.
Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.
This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.
- Conditions
- Dry Eye Syndromes
- Being tested
- Temporary Collagen Inserts
- Keywords
- contact lenses, intolerance, punctal plugs, tear volume, Intolerance to contact lens wear due to dryness symptoms
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Collagen InsertsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular comfort after 6 hours of contact lens wear
Dryness sensation after 6 hours of contact lens wear
Tear film volume before and after 6 hours of contact lens wear
Secondary outcomes (2)
Objective ocular sensitivity after 6 hours of contact lens wear
Tear film and contact lens osmolality after 6 hours of contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Stahl, Dipl-Optom, Principal investigator, VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372034
- Sponsor's protocol ID
- VRRP2005-018
- Status last verified
- Apr 2009
- First submitted
- 3 Sep 2006
- Last updated
- 7 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Punctal Plugs on Tear Volume and Osmolality
- ClinicalTrials.gov ID
- NCT00372034
- Acronym / sponsor ID
- VRRP2005-018
- Conditions
- Dry Eye Syndromes
- Keywords
- contact lenses, intolerance, punctal plugs, tear volume, Intolerance to contact lens wear due to dryness symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.
Detailed description
50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.
Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.
This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Over 18 years of age
Key exclusion criteria (6 listed)
- Corneal refractive surgery
- Contraindications to contact lens wear
- Latex allergy
- Corneal hypoesthesia
- Active corneal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Collagen Inserts | Device | – |
Primary outcome
Ocular comfort after 6 hours of contact lens wear
Dryness sensation after 6 hours of contact lens wear
Tear film volume before and after 6 hours of contact lens wear
2 secondary outcomes
Objective ocular sensitivity after 6 hours of contact lens wear
Tear film and contact lens osmolality after 6 hours of contact lens wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Stahl, Dipl-Optom principal investigator
VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Collagen Inserts in people with Dry Eye Syndromes, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular comfort after 6 hours of contact lens wear. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2009.