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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05741216




Registration number
NCT05741216
Ethics application status
Date submitted
14/02/2023
Date registered
23/02/2023
Date last updated
11/10/2023

Titles & IDs
Public title
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Scientific title
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Secondary ID [1] 0 0
DEJ475-E006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye 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
Other interventions - OTF Ocular Lubricant
Other interventions - Ocular Lubricant

Experimental: OTF Test 1 - One application of ocular lubricant to each eye at night for 5 consecutive nights

Experimental: OTF Test 2 - One application of ocular lubricant to each eye at night for 5 consecutive nights

Experimental: OTF Test 3 - One application of ocular lubricant to each eye at night for 5 consecutive nights

Active Comparator: Ocular lubricant - One drop of ocular lubricant applied to each eye at night for 5 consecutive nights


Other interventions: OTF Ocular Lubricant
Ocular lubricant in 1 of 3 test formulations

Other interventions: Ocular Lubricant
Commercially available ocular lubricant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular comfort
Timepoint [1] 0 0
Up to Day 5

Eligibility
Key inclusion criteria
Key

- Is able to understand and sign an approved information consent letter;

- Habitually wears daily disposable soft contact lenses in both eyes

- Uses rewetting drops on a regular basis;

- Other protocol-defined inclusion criteria may apply.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Routinely sleeps in habitual contact lenses;

- Has any known active ocular disease and/or infection;

- Is pregnant or lactating;

- Other protocol specified exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
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
1/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2023
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
School of Optometry and Vision - Sydney
Recruitment hospital [2] 0 0
Deakin Collaborative Eye Care Clinic, Deakin University - Waurn Ponds
Recruitment postcode(s) [1] 0 0
2052 - Sydney
Recruitment postcode(s) [2] 0 0
3216 - Waurn Ponds
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a
comparator.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05741216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Lead, Dry Eye
Address 0 0
Alcon Research, LLC
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