Dry EyeNCT05741216
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
A study testing OTF Ocular Lubricant and Ocular Lubricant in people with Dry Eye, run by Alcon Research at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- OTF Ocular Lubricant and Ocular Lubricant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 May 2023to 2 Oct 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
- Is able to understand and sign an approved information consent letter;
- Habitually wears daily disposable soft contact lenses in both eyes
- Uses rewetting drops on a regular basis;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Routinely sleeps in habitual contact lenses;
- Has any known active ocular disease and/or infection;
- Is pregnant or lactating;
- Other protocol specified exclusion criteria may apply.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
School of Optometry and Vision
Sydney, New South Wales, 2052
Deakin Collaborative Eye Care Clinic, Deakin University
Waurn Ponds, Victoria, 3216
Canada1 site
School of Optometry and Vision Science, University of Waterloo
Waterloo, Ontario, N2L3G1
About this study
The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.
Read the detailed description
The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.
- Conditions
- Dry Eye
- Being tested
- OTF Ocular Lubricant, 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.
OTF Ocular LubricantOther
Ocular lubricant in 1 of 3 test formulations
Ocular LubricantOther
Also called SYSTANE™ Gel, Genteal™ Gel
Commercially available ocular lubricant
| Study group | Role | What they receive |
|---|---|---|
| OTF Test 1 | Experimental | One application of ocular lubricant to each eye at night for 5 consecutive nights Receives: Other: OTF Ocular Lubricant |
| OTF Test 2 | Experimental | One application of ocular lubricant to each eye at night for 5 consecutive nights Receives: Other: OTF Ocular Lubricant |
| OTF Test 3 | Experimental | One application of ocular lubricant to each eye at night for 5 consecutive nights Receives: Other: OTF Ocular Lubricant |
| Ocular lubricant | Active comparator | One drop of ocular lubricant applied to each eye at night for 5 consecutive nights Receives: Other: Ocular Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular comfort
Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.
Measured: Up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 May 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05741216
- Sponsor's protocol ID
- DEJ475-E006
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT05741216
- Acronym / sponsor ID
- DEJ475-E006
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 23 Feb 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 the ocular comfort of 3 ocular lubricants and a comparator.
Detailed description
The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OTF Test 1 | Experimental | Other: OTF Ocular LubricantOne application of ocular lubricant to each eye at night for 5 consecutive nights |
| OTF Test 2 | Experimental | Other: OTF Ocular LubricantOne application of ocular lubricant to each eye at night for 5 consecutive nights |
| OTF Test 3 | Experimental | Other: OTF Ocular LubricantOne application of ocular lubricant to each eye at night for 5 consecutive nights |
| Ocular lubricant | Active comparator | Other: Ocular LubricantOne drop of ocular lubricant applied to each eye at night for 5 consecutive nights |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is able to understand and sign an approved information consent letter;
- Habitually wears daily disposable soft contact lenses in both eyes
- Uses rewetting drops on a regular basis;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Routinely sleeps in habitual contact lenses;
- Has any known active ocular disease and/or infection;
- Is pregnant or lactating;
- Other protocol specified 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 |
|---|---|---|
| OTF Ocular LubricantOcular lubricant in 1 of 3 test formulations | Other | OTF Test 1, OTF Test 2, OTF Test 3 |
| Ocular LubricantAlso: SYSTANE™ Gel, Genteal™ GelCommercially available ocular lubricant | Other | Ocular lubricant |
Primary outcome
Ocular comfort
Time frame: Up to Day 5
Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTF Ocular Lubricant and Ocular Lubricant in people with Dry Eye, run by Alcon Research at 3 sites in 2 countries.
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 4 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, Canada. 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?
Ocular comfort (time frame: Up to Day 5). 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.