Dry EyeNCT00804791
Residence Time Evaluation of Marketed OTC Ophthalmic Products
A study testing Systane Ultra Lubricant Eye Drops and Unisol 4 Saline Solution in people with Dry Eye, run by Alcon Research.
Trial summary
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products 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?
- Systane Ultra Lubricant Eye Drops and Unisol 4 Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Feb 2009
- 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
- Informed consent and HIPAA read, signed and dated before conducting any procedures.
- Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
- Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
Who cannot join
- History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
- History or evidence of serious ocular trauma in either eye w/i the past 6 months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
- Use of concomitant topical ocular medications during the study period.
- Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
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- Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
- Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1.
- Participation in an investigational drug or device study w/i 30 days of entering this study.
- Additionally, any subject may be declared ineligible for a valid medical reason.
About this study
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
- Conditions
- Dry Eye
- Being tested
- Systane Ultra Lubricant Eye Drops, Unisol 4 Saline Solution
- Keywords
- dry eye, autofluorescence, residence 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 Ultra Lubricant Eye DropsOther
artificial tears solution for lubricating the cornea
Unisol 4 Saline SolutionOther
saline solution for irrigating the cornea
| Study group | Role | What they receive |
|---|---|---|
| Systane | Active comparator | One drop dispensed into each eye Receives: Other: Systane Ultra Lubricant Eye Drops |
| Unisol | Active comparator | One drop dispensed into each eye Receives: Other: Unisol 4 Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Residence Time
Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
Measured: After 8 minutes, then every 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT00804791
- Sponsor's protocol ID
- M-08-11
- Status last verified
- Jan 2012
- First submitted
- 5 Dec 2008
- 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
- Residence Time Evaluation of Marketed OTC Ophthalmic Products
- ClinicalTrials.gov ID
- NCT00804791
- Acronym / sponsor ID
- M-08-11
- Conditions
- Dry Eye
- Keywords
- dry eye, autofluorescence, residence time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 9 Dec 2008 (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 objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products 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 |
|---|---|---|
| Systane | Active comparator | Other: Systane Ultra Lubricant Eye DropsOne drop dispensed into each eye |
| Unisol | Active comparator | Other: Unisol 4 Saline SolutionOne drop dispensed into each eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent and HIPAA read, signed and dated before conducting any procedures.
- Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
- Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
Key exclusion criteria (10 listed)
- History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
- History or evidence of serious ocular trauma in either eye w/i the past 6 months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
- Use of 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 Ultra Lubricant Eye Dropsartificial tears solution for lubricating the cornea | Other | Systane |
| Unisol 4 Saline Solutionsaline solution for irrigating the cornea | Other | Unisol |
Primary outcome
Ocular Surface Residence Time
Time frame: After 8 minutes, then every 2 minutes
Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation 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 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.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Ultra Lubricant Eye Drops and Unisol 4 Saline Solution 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 3 inclusion and 10 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.
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?
Ocular Surface Residence Time (time frame: After 8 minutes, then every 2 minutes). 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.