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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06571656




Registration number
NCT06571656
Ethics application status
Date submitted
23/08/2024
Date registered
26/08/2024

Titles & IDs
Public title
Evaluation of the Safety and Tolerability of Ocular Lubricants
Scientific title
Evaluation of the Safety and Tolerability of Ocular Lubricants
Secondary ID [1] 0 0
DEE253-E002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Disease 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 - FID123359 test formulation
Other interventions - FID123360 test formulation
Other interventions - FID123361 test formulation
Other interventions - FID121843 ocular lubricant

Other: Sequence 1 - FID123359/ FID123360/ FID123361/FID121843: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled. Investigational Product visits will be separated by 2 to 7 days.

Other: Sequence 2 - FID123360/ FID123361/FID121843/ FID123359: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled. Investigational Product visits will be separated by 2 to 7 days.

Other: Sequence 3 - FID123361/FID121843/FID123359/ FID123360: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled. Investigational Product visits will be separated by 2 to 7 days.

Other: Sequence 4 - FID121843/FID123359/ FID123360/ FID123361: One drop in each eye, test formulation or ocular lubricant as randomized, at respective Investigational Product visit. A total of 4 drops per eye will be instilled. Investigational Product visits will be separated by 2 to 7 days.


Other interventions: FID123359 test formulation
Investigational product

Other interventions: FID123360 test formulation
Investigational product

Other interventions: FID123361 test formulation
Investigational product

Other interventions: FID121843 ocular lubricant
Commercially available, preservative-free eye drops
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
Visit 2 (2 to 45 days after the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 days after Visit 2 depending on observed visit windows.
Primary outcome [2] 0 0
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
Timepoint [2] 0 0
Screening Visit through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows.
Primary outcome [3] 0 0
Best Corrected Visual Acuity (BCVA) with Manifest Refraction (MR)
Timepoint [3] 0 0
Screening through Visit 6/Study Exit. Visit 6 will occur 9 to 77 days after Screening Visit, based on observed visit windows.

Eligibility
Key inclusion criteria
Key

* Willing and able to understand and sign an Ethics Committee-approved informed consent form.
* Willing and able to attend all study visits as required by the protocol.
* Exhibits symptoms of dry eye at the Screening Visit.
* Currently uses habitual artificial tears to alleviate dry eye symptoms.
* Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
* Other protocol-specified 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
* Has any known active ocular disease and/or infection.
* Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator, may affect a study outcome variable.
* Has had an ocular injury to either eye in the past 12 weeks prior to screening.
* Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
* Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
* Is pregnant, intends to become pregnant, or is breastfeeding.
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
School of Optometry and Vision - Sydney
Recruitment hospital [2] 0 0
The University of Melbourne, Department of Optometry and Vision Science - Carlton
Recruitment hospital [3] 0 0
Deakin Collaborative Eye Care Clinic - Waurn Ponds
Recruitment postcode(s) [1] 0 0
2052 - Sydney
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 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
Alcon Call Center
Address 0 0
Country 0 0
Phone 0 0
1-888-451-3937
Fax 0 0
Email 0 0
alcon.medinfo@alcon.com
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/NCT06571656