Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00372034




Registration number
NCT00372034
Ethics application status
Date submitted
3/09/2006
Date registered
6/09/2006
Date last updated
7/04/2009

Titles & IDs
Public title
The Effect of Punctal Plugs on Tear Volume and Osmolality
Scientific title
Secondary ID [1] 0 0
VRRP2005-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Syndromes 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular comfort after 6 hours of contact lens wear
Timepoint [1] 0 0
Primary outcome [2] 0 0
Dryness sensation after 6 hours of contact lens wear
Timepoint [2] 0 0
Primary outcome [3] 0 0
Tear film volume before and after 6 hours of contact lens wear
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Objective ocular sensitivity after 6 hours of contact lens wear
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Tear film and contact lens osmolality after 6 hours of contact lens wear
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Over 18 years of age
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Vision CRC, Institute for Eye Research, School of Optometry and Vision Science - Sydney
Recruitment postcode(s) [1] 0 0
2033 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ulrike Stahl, Dipl-Optom
Address 0 0
VisionCRC, School of Optometry and Vision Science, Institute for Eye Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00372034