Dry Eye DiseaseNCT07238699
An Evaluation of the Safety and Tolerability of Ocular Lubricants
A study testing FID123440 test formulation and FID123437 test formulation in people with Dry Eye Disease, run by Alcon Research at 4 sites in Australia.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- FID123440 test formulation and FID123437 test formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesAustralia
- Study dates
- 4 Mar 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
- Subject must be willing and able to attend all study visits as required by the protocol.
- Subject must exhibit symptoms of dry eye at the Screening Visit.
- Subject must currently use artificial tears.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- 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.
- Any ocular injury to either eye in the 12 weeks prior to screening.
- Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
The University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, 3053
School of Optometry and Vision
Sydney, New South Wales, 2052
Ophthalmic Trials Australia
Teneriffe, Queensland, 4005
Deakin Collaborative Eye Care Clinic, Deakin University
Waurn Ponds, Victoria, 3216
About this study
The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.
Read the detailed description
Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.
- Conditions
- Dry Eye Disease
- Being tested
- FID123440 test formulation, FID123437 test formulation
- Keywords
- Itchy eyes, Stinging eyes, Scratchy eyes
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID123440 test formulationOther
Investigational product
FID123437 test formulationOther
Investigational product
FID123440 test formulationOther
Investigational product
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: FID123440, then FID123437 | Experimental | One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods. Receives: Other: FID123440 test formulation; Other: FID123437 test formulation |
| Sequence 2: FID123437, then FID123440 | Experimental | One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods. Receives: Other: FID123437 test formulation; Other: FID123440 test formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Measured: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Measured: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
Best Corrected Visual Acuity (BCVA)
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).
Measured: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start4 Mar 2026
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Dry Eye, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238699
- Sponsor's protocol ID
- DEE253-E003
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Tolerability of Ocular Lubricants
- ClinicalTrials.gov ID
- NCT07238699
- Acronym / sponsor ID
- DEE253-E003
- Conditions
- Dry Eye Disease
- Keywords
- Itchy eyes, Stinging eyes, Scratchy eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.
Detailed description
Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: FID123440, then FID123437 | Experimental | Other: FID123440 test formulation, Other: FID123437 test formulationOne drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods. |
| Sequence 2: FID123437, then FID123440 | Experimental | Other: FID123437 test formulation, Other: FID123440 test formulationOne drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
- Subject must be willing and able to attend all study visits as required by the protocol.
- Subject must exhibit symptoms of dry eye at the Screening Visit.
- Subject must currently use artificial tears.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- 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.
- Any ocular injury to either eye in the 12 weeks prior to screening.
- Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
- Other protocol-defined exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID123440 test formulationInvestigational product | Other | Sequence 1: FID123440, then FID123437 |
| FID123437 test formulationInvestigational product | Other | Sequence 1: FID123440, then FID123437, Sequence 2: FID123437, then FID123440 |
| FID123440 test formulationInvestigational product | Other | Sequence 2: FID123437, then FID123440 |
Primary outcome
Number of Treatment-Emergent Adverse Events (AEs)
Time frame: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Best Corrected Visual Acuity (BCVA)
Time frame: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Dry Eye study director
Alcon Research, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID123440 test formulation and FID123437 test formulation in people with Dry Eye Disease, run by Alcon Research at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events (AEs) (time frame: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.