Dry Eye DiseaseNCT05888519
Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
A study testing FID123300 ocular lubricant, FID123301 ocular lubricant and FID122505 ocular lubricant in people with Dry Eye Disease, run by Alcon Research at 3 sites in Australia.
Trial 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. 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?
- FID123300 ocular lubricant, FID123301 ocular lubricant and FID122505 ocular lubricant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesAustralia
- Study dates
- 24 Jul 2023to 27 Sep 2023
- 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
- Sign an Informed Consent;
- Have dry eye symptoms;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
University of Melbourne, Department of Optometry and Vision Science
Carlton, Victoria, 3053
George Street Eye Centre
Sydney, New South Wales, 2000
Ophthalmic Trials Australia
Teneriffe, Queensland, 4005
About this study
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.
Read the detailed description
Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.
- Conditions
- Dry Eye Disease
- Being tested
- FID123300 ocular lubricant, FID123301 ocular lubricant, FID122505 ocular lubricant
- 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.
FID123300 ocular lubricantOther
Investigational ocular lubricant
FID123301 ocular lubricantOther
Investigational ocular lubricant
FID122505 ocular lubricantOther
Comparator ocular lubricant
| Study group | Role | What they receive |
|---|---|---|
| FID123300/FID123301/FID122505 | Other | 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. Receives: Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant; Other: FID122505 ocular lubricant |
| FID123301/FID122505/FID123300 | Other | 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. Receives: Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant; Other: FID122505 ocular lubricant |
| FID122505/FID123300/FID123301 | Other | 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. Receives: Other: FID123300 ocular lubricant; Other: FID123301 ocular lubricant; Other: FID122505 ocular lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) with manifest refraction, at distance
BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
Measured: Day 1, each wear period. A wear period is 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 Jul 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
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
- None (open label)
- Enrolment
- 47 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
- NCT05888519
- Sponsor's protocol ID
- DEP918-E001
- Status last verified
- Oct 2023
- First submitted
- 9 May 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
- ClinicalTrials.gov ID
- NCT05888519
- Acronym / sponsor ID
- DEP918-E001
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 5 Jun 2023 (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 investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
Detailed description
Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FID123300/FID123301/FID122505 | Other | Other: FID123300 ocular lubricant, Other: FID123301 ocular lubricant, Other: FID122505 ocular lubricantFID123300 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. |
| FID123301/FID122505/FID123300 | Other | Other: FID123300 ocular lubricant, Other: FID123301 ocular lubricant, Other: FID122505 ocular lubricantFID123301 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. |
| FID122505/FID123300/FID123301 | Other | Other: FID123300 ocular lubricant, Other: FID123301 ocular lubricant, Other: FID122505 ocular lubricantFID122505 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sign an Informed Consent;
- Have dry eye symptoms;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| FID123300 ocular lubricantInvestigational ocular lubricant | Other | FID122505/FID123300/FID123301, FID123300/FID123301/FID122505, FID123301/FID122505/FID123300 |
| FID123301 ocular lubricantInvestigational ocular lubricant | Other | FID122505/FID123300/FID123301, FID123300/FID123301/FID122505, FID123301/FID122505/FID123300 |
| FID122505 ocular lubricantComparator ocular lubricant | Other | FID122505/FID123300/FID123301, FID123300/FID123301/FID122505, FID123301/FID122505/FID123300 |
Primary outcome
Best corrected visual acuity (BCVA) with manifest refraction, at distance
Time frame: Day 1, each wear period. A wear period is 1 day.
BCVA will be collected for each eye individually 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 Oct 2023.
- Individual participant dataSharing planned: No
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID123300 ocular lubricant, FID123301 ocular lubricant and FID122505 ocular lubricant in people with Dry Eye Disease, run by Alcon Research at 3 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 3 inclusion and 4 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Best corrected visual acuity (BCVA) with manifest refraction, at distance (time frame: Day 1, each wear period. A wear period is 1 day.). 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 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.