Dry Eye SyndromeNCT01252121
Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
A study testing Systane Ultra Lubricant Eye Drops, Hialid 0.1 Artificial Tears Eye Drops and Unisol 4 Saline Solution in people with Dry Eye Syndrome, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Systane Ultra Lubricant Eye Drops, Hialid 0.1 Artificial Tears Eye Drops and Unisol 4 Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mild to moderate dry eye as defined in the protocol.
- Able and willing to follow instructions.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any medical condition that may affect the results of the study.
- History or evidence of ocular or intraocular surgery within the past six months.
- History of intolerance or hypersensitivity to any component of the study medications.
- Use of concomitant topical ocular medications during the study period.
- Ocular conditions that may preclude safe administration of the test article.
- Unwilling to discontinue contact lens wear during the study period.
- Participation in an investigational drug or device study within 30 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.
- Conditions
- Dry Eye Syndrome
- Being tested
- Systane Ultra Lubricant Eye Drops, Hialid 0.1 Artificial Tears Eye Drops, Unisol 4 Saline Solution
- Keywords
- Dry Eye, Ocular Retention 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
One drop in study eye, one time, during office visit.
Hialid 0.1 Artificial Tears Eye DropsOther
One drop in study eye, one time, during office visit.
Unisol 4 Saline SolutionOther
One drop in study eye, one time, during office visit.
| Study group | Role | What they receive |
|---|---|---|
| Systane, Hialid, Unisol | Other | 1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution |
| Systane, Unisol, Hialid | Other | 1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution |
| Hialid, Systane, Unisol | Other | 1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution |
| Hialid, Unisol, Systane | Other | 1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution |
| Unisol, Systane, Hialid | Other | 1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; Other: Unisol 4 Saline Solution |
| Unisol, Hialid, Systane | Other | 1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. Receives: Other: Systane Ultra Lubricant Eye Drops; Other: Hialid 0.1 Artificial Tears Eye Drops; 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 defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.
Measured: Time to event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startOct 2010
- 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 Eye SyndromeStudies 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
- 27 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
- NCT01252121
- Sponsor's protocol ID
- RDG-10-275
- Other IDs
- CS-10-01
- Status last verified
- May 2012
- First submitted
- 30 Nov 2010
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
- ClinicalTrials.gov ID
- NCT01252121
- Acronym / sponsor ID
- RDG-10-275
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye, Ocular Retention Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Dec 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 ocular retention time of Systane Ultra compared to Hialid and saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Systane, Hialid, Unisol | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. |
| Systane, Unisol, Hialid | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. |
| Hialid, Systane, Unisol | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. |
| Hialid, Unisol, Systane | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. |
| Unisol, Systane, Hialid | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. |
| Unisol, Hialid, Systane | Other | Other: Systane Ultra Lubricant Eye Drops, Other: Hialid 0.1 Artificial Tears Eye Drops, Other: Unisol 4 Saline Solution1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with mild to moderate dry eye as defined in the protocol.
- Able and willing to follow instructions.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Any medical condition that may affect the results of the study.
- History or evidence of ocular or intraocular surgery within the past six months.
- History of intolerance or hypersensitivity to any component of the study medications.
- Use of concomitant topical ocular medications during the study period.
- Ocular conditions that may preclude safe administration of the test article.
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 DropsOne drop in study eye, one time, during office visit. | Other | Hialid, Systane, Unisol, Hialid, Unisol, Systane, Systane, Hialid, Unisol, Systane, Unisol, Hialid, Unisol, Hialid, Systane, Unisol, Systane, Hialid |
| Hialid 0.1 Artificial Tears Eye DropsOne drop in study eye, one time, during office visit. | Other | Hialid, Systane, Unisol, Hialid, Unisol, Systane, Systane, Hialid, Unisol, Systane, Unisol, Hialid, Unisol, Hialid, Systane, Unisol, Systane, Hialid |
| Unisol 4 Saline SolutionOne drop in study eye, one time, during office visit. | Other | Hialid, Systane, Unisol, Hialid, Unisol, Systane, Systane, Hialid, Unisol, Systane, Unisol, Hialid, Unisol, Hialid, Systane, Unisol, Systane, Hialid |
Primary outcome
Ocular surface residence time
Time frame: Time to event
Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.
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 30 Oct 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, Hialid 0.1 Artificial Tears Eye Drops and Unisol 4 Saline Solution in people with Dry Eye Syndrome, 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 8 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 30 Oct 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: Time to event). 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 30 Oct 2012.