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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/NCT05573360




Registration number
NCT05573360
Ethics application status
Date submitted
4/10/2022
Date registered
10/10/2022
Date last updated
6/07/2023

Titles & IDs
Public title
Evaluation of Safety and Tolerability of Ocular Lubricants
Scientific title
Evaluation of Safety and Tolerability of Ocular Lubricants
Secondary ID [1] 0 0
DEE253-E001
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 - NGF5-A test formulation
Other interventions - NGF4-B test formulation
Other interventions - NGF6-B test formulation
Other interventions - NGF6-E test formulation
Other interventions - Systane eye drop

Other: Sequence 1 - NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Other: Sequence 2 - NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Other: Sequence 3 - NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Other: Sequence 4 - NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation

Other: Sequence 5 - Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation


Other interventions: NGF5-A test formulation
One drop of investigational product instilled on the eye

Other interventions: NGF4-B test formulation
One drop of investigational product instilled on the eye

Other interventions: NGF6-B test formulation
One drop of investigational product instilled on the eye

Other interventions: NGF6-E test formulation
One drop of investigational product instilled on the eye

Other interventions: Systane eye drop
One drop of commercial product instilled on the eye
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Treatment-Emergent Adverse Events (AEs)
Timepoint [1] 0 0
Up to Day 30 (Study Exit)
Primary outcome [2] 0 0
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
Timepoint [2] 0 0
Screening, up to Day 30 (Study Exit)
Primary outcome [3] 0 0
Mean Total Ocular Surface Staining Score
Timepoint [3] 0 0
Screening, up to Day 30 (Study Exit)
Primary outcome [4] 0 0
Mean Best Corrected Visual Acuity (BCVA)
Timepoint [4] 0 0
Screening, up to Day 30 (Study Exit)
Primary outcome [5] 0 0
Number of Device Deficiencies
Timepoint [5] 0 0
Up to Day 30 (Study Exit)

Eligibility
Key inclusion criteria
Key

- Able to understand and sign an informed consent form.

- Willing and able to attend all study visits as required by the protocol.

- Other protocol-defined inclusion criteria may apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any known active ocular disease.

- Any systemic condition that, in the opinion of the investigator, may affect a study
outcome variable.

- Any ocular injury to either eye in the past 12 weeks prior to screening.

- Other protocol-defined 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
Crossover
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
16/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alcon Investigator 8169 - Carlton
Recruitment hospital [2] 0 0
Alcon Investigator 8214 - Waurn Ponds
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3216 - Waurn Ponds

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 safety profile of test formulations for an
artificial tear product versus a comparator product.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05573360
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