Dry EyeNCT01023464
Tear Film Break-Up Time Evaluation of FID 114657
A study testing FID114657 and SootheXP Emollient (Lubricant) Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
To evaluate the effects of FID 114657 on tear film break-up time in 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?
- FID114657 and SootheXP Emollient (Lubricant) Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to 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
- The informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
- Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' 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 <5 seconds in at least one eye; > Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
- Able and willing to follow study instructions.
- Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
- Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.
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 of intolerance or hypersensitivity to any component of the study medications.
- 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.
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- Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude safe administration of the test article.
- Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
- Enrollment of investigator's office staff, relatives, or members of their respective households; or enrollment of more than one member of the same household.
- Participation in an investigational drug or device study within 30 days of entering this study.
About this study
To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.
- Conditions
- Dry Eye
- Being tested
- FID114657, SootheXP Emollient (Lubricant) Eye Drops
- Keywords
- 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.
FID114657Other
artificial tears
SootheXP Emollient (Lubricant) Eye DropsOther
artificial tears
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Other | FID 114657 or SootheXP Receives: Other: FID114657; Other: SootheXP Emollient (Lubricant) Eye Drops |
| Period 2 | Other | FID 114657 or SootheXP Receives: Other: FID114657; Other: SootheXP Emollient (Lubricant) Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear film break-up time (TFBUT)
Measured: Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 120 minutes post instillation.
Secondary outcomes (1)
Acute comfort
Measured: Immediately post instillation of test article
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2009
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 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
- NCT01023464
- Sponsor's protocol ID
- C-09-030
- Status last verified
- Feb 2012
- First submitted
- 25 Nov 2009
- 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
- Tear Film Break-Up Time Evaluation of FID 114657
- ClinicalTrials.gov ID
- NCT01023464
- Acronym / sponsor ID
- C-09-030
- Conditions
- Dry Eye
- Keywords
- tear film break-up time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- First posted
- 2 Dec 2009 (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.
To evaluate the effects of FID 114657 on tear film break-up time in dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Other | Other: FID114657, Other: SootheXP Emollient (Lubricant) Eye DropsFID 114657 or SootheXP |
| Period 2 | Other | Other: FID114657, Other: SootheXP Emollient (Lubricant) Eye DropsFID 114657 or SootheXP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
- Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics at Visit 1 (Screening): Patients' 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 <5 seconds in at least one eye; > Grade 1 for Meibomian Gland Expression in both eyes; Evidence of missing meibomian glands in both eyes.
- Able and willing to follow study instructions.
- Patients must have best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
- Patients must not have used any topical ocular drops for approximately 24 hours prior to Visit 1.
Key exclusion criteria (11 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 of intolerance or hypersensitivity to any component of the study medications.
- 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.
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 |
|---|---|---|
| FID114657artificial tears | Other | Period 1, Period 2 |
| SootheXP Emollient (Lubricant) Eye Dropsartificial tears | Other | Period 1, Period 2 |
Primary outcome
tear film break-up time (TFBUT)
Time frame: Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 120 minutes post instillation.
1 secondary outcome
Acute comfort
Time frame: Immediately post instillation of test article
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.
Questions about this trial
What is this clinical trial studying?
A study testing FID114657 and SootheXP Emollient (Lubricant) Eye Drops 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 5 inclusion and 11 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.
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?
tear film break-up time (TFBUT) (time frame: Instill assigned test article to both eyes and begin timing the evaluation process. Measure TFBUT at 15, 30, 60 and 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 NCT01023464, 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.