Dry EyeNCT01066988
Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
A study testing ORB Ocular Emulsion and SootheXP Emollient (Lubricant) Eye Drops in people with Dry Eye, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients. 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?
- ORB Ocular Emulsion and SootheXP Emollient (Lubricant) Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 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
- Patients (minimum age 18) meeting specific criteria for dry eye.
Who cannot join
- Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
- History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.
- Conditions
- Dry Eye
- Being tested
- ORB Ocular Emulsion, SootheXP Emollient (Lubricant) Eye Drops
- Keywords
- lipid layer thickness
- 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.
ORB Ocular EmulsionOther
lubricant eye drop
SootheXP Emollient (Lubricant) Eye DropsOther
lubricant eye drop
| Study group | Role | What they receive |
|---|---|---|
| Right Eye | Other | ORB Ocular Emulsion or SootheXP Receives: Other: ORB Ocular Emulsion |
| Left Eye | Other | ORB Ocular Emulsion or SootheXP Receives: Other: SootheXP Emollient (Lubricant) Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid layer thickness
Measured: Baseline through 120 minutes post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT01066988
- Sponsor's protocol ID
- C-09-046
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2010
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.
PubMed 21750611
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Investigational Lubricant Eye Drop on Lipid Layer Thickness
- ClinicalTrials.gov ID
- NCT01066988
- Acronym / sponsor ID
- C-09-046
- Conditions
- Dry Eye
- Keywords
- lipid layer thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- First posted
- 11 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 evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Eye | Other | Other: ORB Ocular EmulsionORB Ocular Emulsion or SootheXP |
| Left Eye | Other | Other: SootheXP Emollient (Lubricant) Eye DropsORB Ocular Emulsion or SootheXP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (minimum age 18) meeting specific criteria for dry eye.
Key exclusion criteria (2 listed)
- Use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. In addition, cannot use any topical ocular drugs during study period.
- History or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.
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 |
|---|---|---|
| ORB Ocular Emulsionlubricant eye drop | Other | Right Eye |
| SootheXP Emollient (Lubricant) Eye Dropslubricant eye drop | Other | Left Eye |
Primary outcome
Lipid layer thickness
Time frame: Baseline through 120 minutes post instillation
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 18 Nov 2016.
- Results publication: PubMed 21750611Benelli U. Systane lubricant eye drops in the management of ocular dryness. Clin Ophthalmol. 2011;5:783-90. doi: 10.2147/OPTH.S13773. Epub 2011 Jun 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORB Ocular Emulsion and SootheXP Emollient (Lubricant) Eye Drops in people with Dry Eye, run by Alcon Research at 1 site in United States.
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 18 Nov 2016. 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 United States. 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?
Lipid layer thickness (time frame: Baseline through 120 minutes post instillation). 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 NCT01066988, 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 18 Nov 2016.