Dry EyeNCT01368198
Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
A study testing Systane Balance Lubricating Eye Drops and OPTIVE™ in people with Dry Eye, run by Alcon Research at 2 sites in 2 countries.
Trial summary
The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Balance Lubricating Eye Drops and OPTIVE™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must be 18 years of age or older;
- The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
- The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
- The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
- Subjects' self-assessment of dry eye status (answer of at least "some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?");
- TFBUT measured with DET ≤ 5 seconds in at least one eye;
- Grade 1 for meibomian gland expression in both eyes;
- Evidence of missing meibomian glands in both eyes.
Who cannot join
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History or evidence of serious ocular trauma in either eye within the past six months.
- Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of any concomitant topical ocular medications during the study period.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation.
- Participation in an investigational drug or device study within 30 days of entering this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
United Kingdom1 site
OTG Research & Consultancy
London, England, SW1E 6AU
About this study
Official title: The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
The primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.
Read the detailed description
The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.
- Conditions
- Dry Eye
- Being tested
- Systane Balance Lubricating Eye Drops, OPTIVE™
- Keywords
- Ocular Emulsion, OPTIVE™ Lubricant, Tear Film Break Up Time
- 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.
Systane Balance Lubricating Eye DropsOther
Also called Ocular Emulsion
One instillation of the eye drop in each eye
OPTIVE™Other
Also called Optive
One instillation of the eye drop in each eye
| Study group | Role | What they receive |
|---|---|---|
| Ocular Emulsion | Active comparator | An Ocular Emulsion Receives: Other: Systane Balance Lubricating Eye Drops |
| OPTIVE™ | Active comparator | An OPTIVE™ Receives: Other: OPTIVE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the tear film break-up time using DET sodium fluorescein strips.
Measured: Enrollment Test visit 1
Secondary outcomes (1)
Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.
Measured: Enrollment Test visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optometric Technology Group Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368198
- Sponsor's protocol ID
- ID11-10
- Status last verified
- Jan 2012
- First submitted
- 6 May 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Extended Tear Film Break Up Time (TFBUT) With an Ocular Emulsion
- ClinicalTrials.gov ID
- NCT01368198
- Acronym / sponsor ID
- ID11-10
- Conditions
- Dry Eye
- Keywords
- Ocular Emulsion, OPTIVE™ Lubricant, Tear Film Break Up Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Optometric Technology Group Ltd
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jun 2011 (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 primary objective of this investigation will be to quantify the increase in tear film break-up time (TFBUT) associated with the instillation of a single eyedrop of an Ocular Emulsion in dry eye sufferers.
Detailed description
The secondary objective of this investigation will be to compare the tear film break up time measured with two different techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ocular Emulsion | Active comparator | Other: Systane Balance Lubricating Eye DropsAn Ocular Emulsion |
| OPTIVE™ | Active comparator | Other: OPTIVE™An OPTIVE™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject must be 18 years of age or older;
- The subject must have a best corrected visual acuity of 0.6 LogMAR (~6/24) or better in each eye
- The subject must not have used any topical ocular drops for approximately 24 hours prior to the enrolment/screening visit
- The subject must be classified as dry eye at enrolment/screening visit according to the following criteria:
Key exclusion criteria (7 listed)
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History or evidence of serious ocular trauma in either eye within the past six months.
- Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of any concomitant topical ocular medications during the study period.
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 |
|---|---|---|
| Systane Balance Lubricating Eye DropsAlso: Ocular EmulsionOne instillation of the eye drop in each eye | Other | Ocular Emulsion |
| OPTIVE™Also: OptiveOne instillation of the eye drop in each eye | Other | OPTIVE™ |
Primary outcome
Measurement of the tear film break-up time using DET sodium fluorescein strips.
Time frame: Enrollment Test visit 1
1 secondary outcome
Measurement of the tear film break-up time in a non invasive manner using the Tearscope®. Measurement of the tear film break-up time in a non invasive manner using the Tearscope®.
Time frame: Enrollment Test visit 2
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 2 Feb 2012.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Balance Lubricating Eye Drops and OPTIVE™ in people with Dry Eye, run by Alcon Research at 2 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 8 inclusion and 7 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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?
Measurement of the tear film break-up time using DET sodium fluorescein strips. (time frame: Enrollment Test visit 1). 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 2 Feb 2012.