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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Devices - Temporary Collagen Inserts

Treatment: Devices: Temporary Collagen Inserts


Intervention code [1] 0 0
Treatment: Devices
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
Gender
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
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00372034
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

Summary results
Other publications