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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05888519




Registration number
NCT05888519
Ethics application status
Date submitted
9/05/2023
Date registered
5/06/2023
Date last updated
11/10/2023

Titles & IDs
Public title
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Scientific title
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
Secondary ID [1] 0 0
DEP918-E001
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 - FID123300 ocular lubricant
Other interventions - FID123301 ocular lubricant
Other interventions - FID122505 ocular lubricant

Other: FID123300/FID123301/FID122505 - FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Other: FID123301/FID122505/FID123300 - FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.

Other: FID122505/FID123300/FID123301 - FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.


Other interventions: FID123300 ocular lubricant
Investigational ocular lubricant

Other interventions: FID123301 ocular lubricant
Investigational ocular lubricant

Other interventions: FID122505 ocular lubricant
Comparator ocular lubricant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best corrected visual acuity (BCVA) with manifest refraction, at distance
Timepoint [1] 0 0
Day 1, each wear period. A wear period is 1 day.

Eligibility
Key inclusion criteria
Key

* Sign an Informed Consent;
* Have dry eye symptoms;
* 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
* Ocular abnormalities;
* Active ocular infection or inflammation not associated with dry eye;
* History of ocular or intraocular surgery;
* 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
24/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2023
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
George Street Eye Centre - Sydney
Recruitment hospital [2] 0 0
Ophthalmic Trials Australia - Teneriffe
Recruitment hospital [3] 0 0
University of Melbourne, Department of Optometry and Vision Science - Carlton
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
4005 - Teneriffe
Recruitment postcode(s) [3] 0 0
3053 - Carlton

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 investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
Trial website
https://clinicaltrials.gov/study/NCT05888519
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05888519