Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001375549
Ethics application status
Approved
Date submitted
1/10/2024
Date registered
20/11/2024
Date last updated
20/11/2024
Date data sharing statement initially provided
20/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the experiences from dry eye disease patients in terms of diagnosis and treatment options
Scientific title
Assessing the experiences from dry eye disease patients in terms of diagnosis and treatment options
Secondary ID [1] 313080 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 335321 0
Condition category
Condition code
Eye 331894 331894 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a questionnaire designed to be administered either on paper or with an online form to adults (18 years and over) with clinically diagnosed dry eye disease. The premise of the questionnaire is to garner information on assessment and treatment of dry eye disease with an aim to ascertain information on pros and cons of current dry eye disease management.
The questionnaire will take less than 10 minutes to complete and is administered in the english language.
Intervention code [1] 329637 0
Not applicable
Comparator / control treatment
None - this is not a clinical interventional trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339509 0
To ascertain the perspective of dry eye treatment from dry eye patients
Timepoint [1] 339509 0
The primary outcome is assessed at only one timepoint - at the time of questionnaire administration
Secondary outcome [1] 440252 0
Nil
Timepoint [1] 440252 0
N/A

Eligibility
Key inclusion criteria
* 18 years or older, male or female
* Clinically diagnosed with dry eye disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis
As this is a qualitative questionnaire, no statistical methods were applied to obtain a sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2024
Actual
Date of last participant enrolment
Anticipated
13/12/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26592 0
India
State/province [1] 26592 0

Funding & Sponsors
Funding source category [1] 317525 0
Commercial sector/Industry
Name [1] 317525 0
nthalmic Pty Ltd
Country [1] 317525 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
nthalmic Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319827 0
None
Name [1] 319827 0
Address [1] 319827 0
Country [1] 319827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316236 0
Royal Pune Independent Ethics Committee
Ethics committee address [1] 316236 0
Ethics committee country [1] 316236 0
India
Date submitted for ethics approval [1] 316236 0
09/09/2024
Approval date [1] 316236 0
11/09/2024
Ethics approval number [1] 316236 0

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

Contacts
Principal investigator
Name 137242 0
Mrs Jennie Diec
Address 137242 0
nthalmic Pty Ltd. Address: Level 3, Suite 2, 2A Lord St, Botany NSW 2019
Country 137242 0
Australia
Phone 137242 0
+61 2 9037 7700
Fax 137242 0
Email 137242 0
j.diec@nthalmic.com
Contact person for public queries
Name 137243 0
Jennie Diec
Address 137243 0
nthalmic Pty Ltd. Address: Level 3, Suite 2, 2A Lord St, Botany NSW 2019
Country 137243 0
Australia
Phone 137243 0
+61 2 9037 7700
Fax 137243 0
Email 137243 0
j.diec@nthalmic.com
Contact person for scientific queries
Name 137244 0
Jennie Diec
Address 137244 0
nthalmic Pty Ltd. Address: Level 3, Suite 2, 2A Lord St, Botany NSW 2019
Country 137244 0
Australia
Phone 137244 0
+61 2 9037 7700
Fax 137244 0
Email 137244 0
j.diec@nthalmic.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.