Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000143820
Ethics application status
Not yet submitted
Date submitted
26/01/2012
Date registered
1/02/2012
Date last updated
1/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Under-Recognition of Allergic conjunctivitis in Patients with Allergic Rhinitis
Scientific title
The Effect of Olopatadine Hydrochloride on total ocular symptoms score in Non-allergic conjunctivitis/rhinitis individuals.
Secondary ID [1] 279801 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 285682 0
allergic conjunctivitis 285719 0
Condition category
Condition code
Eye 285869 285869 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked about their indirect symptoms of AC (squinting, blinking, frontal headaches or eyelid dermatitis) to assess whether they suffer. Then total Ocular Symptom Score (TOSS) (tearing, itching and eye redness) will be assessed.
Then, one drop of olopatadine hydrochloride to each eye, ONCE ONLY.
Then 5 minutes will pass before assessing TOSS again.
Intervention code [1] 284127 0
Treatment: Drugs
Comparator / control treatment
Control group will be used to determine if the lubricating effects of the olopatadine eye drops is acting as the relieving factor in the intervention group
Control group
Active

Outcomes
Primary outcome [1] 286367 0
Total ocular symptoms score
Timepoint [1] 286367 0
pre-administration of olopatadine hydrochloride and then at 5minutes post-administration to detect a change in total ocular symptoms score
Secondary outcome [1] 295694 0
nil
Timepoint [1] 295694 0
nil

Eligibility
Key inclusion criteria
No allergic conjunctivitis
Over 18 years
Not pregnant
CONFIRMED PARTICIPANTS CANT HAVE AR/AC
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
allergic conjunctivitis/rhinitis

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)
Patients attending an allergist's outpatients clinic are asked if they would like to participate in this study. if they consent, then they are assessed for symptoms and signs of allergic conjunctivitis. If they do not have any history or symptoms, then they are administered olopatadine hydrochloride to determine if they improved total ocular symptoms scores in patients without allergic conjunctivitis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284579 0
Self funded/Unfunded
Name [1] 284579 0
A/Prof Peter Smith
Country [1] 284579 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Smith
Address
Pacific Private Clinic
123 Nerang St
Southport
Q 4215
Country
Australia
Secondary sponsor category [1] 283496 0
None
Name [1] 283496 0
nil
Address [1] 283496 0
nil
Country [1] 283496 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286566 0
Ethics committee address [1] 286566 0
Ethics committee country [1] 286566 0
Date submitted for ethics approval [1] 286566 0
06/02/2012
Approval date [1] 286566 0
Ethics approval number [1] 286566 0

Summary
Brief summary
Aim:
To determine the most effective way of detecting the incidence of allergic conjunctivitis (AC).
Method:
The first step includes asking patients in an allergy specialist's outpatient clinic about their Total
Ocular Symptom Score (tearing, itching and eye redness), then asking them about indirect
symptoms of AC (squinting, blinking, frontal headaches or eyelid dermatitis), and finally using
an olopatadine challenge to determine if any chronic, undetected symptoms of AC are relieved
and thus suffered.
A control group will be used to determine if the lubricating effects of the olopatadine eye drops
is acting as the relieving factor in the intervention group.
Trial website
n/a
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33686 0
Address 33686 0
Country 33686 0
Phone 33686 0
Fax 33686 0
Email 33686 0
Contact person for public queries
Name 16933 0
A/Prof Peter Smith
Address 16933 0
Pacific Private Clinic
Level 5 123 Nerang St
Southport
Queensland 4215
Country 16933 0
Australia
Phone 16933 0
+617 5591 5744
Fax 16933 0
Email 16933 0
[email protected]
Contact person for scientific queries
Name 7861 0
A/Prof Peter Smith
Address 7861 0
Pacific Private Clinic
Level 5 123 Nerang St
Southport
Queensland 4215
Country 7861 0
Australia
Phone 7861 0
+617 5591 5744
Fax 7861 0
Email 7861 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.