Ocular ComfortNCT04963543
Evaluation of Comfort in Symptomatic Contact Lens Wearers
A study testing FID123238 in people with Ocular Comfort, run by Alcon Research at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Comfort
- What is being tested?
- FID123238
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2021to 29 Oct 2021
- 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;
- Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
- Has a pair of spectacles for vision correction.
- 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-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.
Read the detailed description
The duration of individual participation is six days.
- Conditions
- Ocular Comfort
- Being tested
- FID123238
- Keywords
- Contact Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID123238Other
Lubricant applied to the ocular surface
| Study group | Role | What they receive |
|---|---|---|
| FID123238 | Experimental | FID123238 applied to the ocular surface, 1 application per day, for five consecutive days Receives: Other: FID123238 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort, collected for each eye
A visual analogue scale will be used
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start22 Jul 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular ComfortStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT04963543
- Sponsor's protocol ID
- DEJ475-E003
- Status last verified
- Nov 2021
- First submitted
- 6 Jul 2021
- Last updated
- 3 Nov 2021
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Comfort in Symptomatic Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT04963543
- Acronym / sponsor ID
- DEJ475-E003
- Conditions
- Ocular Comfort
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 15 Jul 2021 (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 comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.
Detailed description
The duration of individual participation is six days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FID123238 | Experimental | Other: FID123238FID123238 applied to the ocular surface, 1 application per day, for five consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is able to understand and sign an approved information consent letter;
- Habitually wears daily disposable soft contact lenses in both eyes;
- Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
- Has a pair of spectacles for vision correction.
- 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-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 |
|---|---|---|
| FID123238Lubricant applied to the ocular surface | Other | FID123238 |
Primary outcome
Comfort, collected for each eye
Time frame: Up to Day 6
A visual analogue scale will be used
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 3 Nov 2021.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID123238 in people with Ocular Comfort, run by Alcon Research at 1 site in Canada.
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 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Comfort, collected for each eye (time frame: Up to Day 6). 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 3 Nov 2021.