Dry EyePhase 4NCT01227226
Tear Osmolarity Over Time With Artificial Tears
A Phase 4 study testing Artificial tears in people with Dry Eye, run by Hom, Milton M., OD, FAAO at 1 site in United States.
Trial summary
The effect of artificial tears on tear osmolarity 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?
- Artificial tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 2011
- Phase
- Phase 4
- 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
- Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good \& stable overall health. Patient likely to comply with study guidelines \& study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)
- -
Who cannot join
- Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
- Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week
Trial locations and contacts
1 site in 1 country.
About this study
The effect of artificial tears on tear osmolarity
Read the detailed description
Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.
- Conditions
- Dry Eye
- Being tested
- Artificial tears
- Keywords
- Dry eye
- 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.
Artificial tearsDrug
Also called Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tears
Instill one drop of artificial tears
| Study group | Role | What they receive |
|---|---|---|
| Refresh tears | Active comparator | Allergan's Refresh tears artificial tear Receives: Drug: Artificial tears |
| Systane Ultra | Active comparator | Alcon's Systane Ultra artificial tear Receives: Drug: Artificial tears |
| Visine | Active comparator | Visine artificial tear Receives: Drug: Artificial tears |
| Blink tears | Active comparator | AMO's blink tears artificial tear Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear osmolarity
Tear osmolarity measured with TearLab instrument
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
- Investigators
- Milton M Hom, OD FAAO, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227226
- Sponsor's protocol ID
- 06
- Status last verified
- Feb 2011
- First submitted
- 21 Oct 2010
- Last updated
- 7 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Osmolarity Over Time With Artificial Tears
- ClinicalTrials.gov ID
- NCT01227226
- Acronym / sponsor ID
- 06
- Conditions
- Dry Eye
- Keywords
- Dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 25 Oct 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 effect of artificial tears on tear osmolarity
Detailed description
Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Refresh tears | Active comparator | Drug: Artificial tearsAllergan's Refresh tears artificial tear |
| Systane Ultra | Active comparator | Drug: Artificial tearsAlcon's Systane Ultra artificial tear |
| Visine | Active comparator | Drug: Artificial tearsVisine artificial tear |
| Blink tears | Active comparator | Drug: Artificial tearsAMO's blink tears artificial tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good \& stable overall health. Patient likely to comply with study guidelines \& study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)
- -
Key exclusion criteria (2 listed)
- Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
- Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week
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 |
|---|---|---|
| Artificial tearsAlso: Allergan's Refresh tears, Alcon's Systane Ultra, Johnson and Johnson's Visine, AMO's blink tearsInstill one drop of artificial tears | Drug | Blink tears, Refresh tears, Systane Ultra, Visine |
Primary outcome
Tear osmolarity
Time frame: 2 days
Tear osmolarity measured with TearLab instrument
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2011.
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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.
Milton M Hom, OD FAAO principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artificial tears in people with Dry Eye, run by Hom, Milton M., OD, FAAO 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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 osmolarity (time frame: 2 days). 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 7 Feb 2011.