Dry EyeNCT01077011
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel
A study testing Lubricant eye drop FID 115958D and GenTeal Gel in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel. 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?
- Lubricant eye drop FID 115958D and GenTeal Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2010
- 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
- Documented diagnosis of dry eye
Who cannot join
- Must not have worn contact lenses within 12 hours preceding enrollment
- Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
About this study
The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.
- Conditions
- Dry Eye
- Being tested
- Lubricant eye drop FID 115958D, GenTeal Gel
- Keywords
- Dry eye, artificial tears
- 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.
Lubricant eye drop FID 115958DOther
1 drop in each eye, one time
GenTeal GelOther
1 drop in each eye, one time
| Study group | Role | What they receive |
|---|---|---|
| Lubricant eye drop | Experimental | Lubricant eye drop Receives: Other: Lubricant eye drop FID 115958D |
| GenTeal Gel | Active comparator | GenTeal Gel Receives: Other: GenTeal Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-minute visual blur profile
Measured: Through 3 minutes (post-instillation)
Overall Acceptability
Measured: Immediately upon instillation
Secondary outcomes (1)
Drop Comfort Upon Instillation
Measured: Immediately upon installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077011
- Sponsor's protocol ID
- C-09-060
- Status last verified
- Jan 2012
- First submitted
- 18 Feb 2010
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel
- ClinicalTrials.gov ID
- NCT01077011
- Acronym / sponsor ID
- C-09-060
- Conditions
- Dry Eye
- Keywords
- Dry eye, artificial tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (actual)
- First posted
- 26 Feb 2010 (estimated)
- 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 compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubricant eye drop | Experimental | Other: Lubricant eye drop FID 115958DLubricant eye drop |
| GenTeal Gel | Active comparator | Other: GenTeal GelGenTeal Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented diagnosis of dry eye
Key exclusion criteria (2 listed)
- Must not have worn contact lenses within 12 hours preceding enrollment
- Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment
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 |
|---|---|---|
| Lubricant eye drop FID 115958D1 drop in each eye, one time | Other | Lubricant eye drop |
| GenTeal Gel1 drop in each eye, one time | Other | GenTeal Gel |
Primary outcome
Three-minute visual blur profile
Time frame: Through 3 minutes (post-instillation)
Overall Acceptability
Time frame: Immediately upon instillation
1 secondary outcome
Drop Comfort Upon Instillation
Time frame: Immediately upon installation
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 21 Nov 2016.
- Results publicationhttp://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lubricant eye drop FID 115958D and GenTeal Gel in people with Dry Eye, run by Alcon Research.
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 1 inclusion and 2 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Three-minute visual blur profile (time frame: Through 3 minutes (post-instillation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077011, which also lists 1 linked publication.
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 21 Nov 2016.