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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05573360




Registration number
NCT05573360
Ethics application status
Date submitted
4/10/2022
Date registered
10/10/2022

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
Trial website
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

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05573360