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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
Date last updated
20/11/2024

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
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
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
The purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.
Trial website
https://clinicaltrials.gov/study/NCT06571656
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06571656