Dry EyePhase 4NCT00622037
Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
A Phase 4 study testing PEG-400 based artificial tear and Systane in people with Dry Eye, run by Bp Consulting, Inc at 1 site in United States.
Trial summary
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial. 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?
- PEG-400 based artificial tear and Systane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2008
- 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
- Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
- Physician assessment of mild-moderate dry eye
- Patient willing to instill drops QID and complete entire length of protocol.
- TBUT < 10 seconds
- BCVA of 20/30 or better
Who cannot join
- Current topical cyclosporine use (Restasis)
- Current Systane use
- Refractive surgery within the last 6 months
- Oral or topical corticosteroid use
- Severe dry eye patients by physician assessment
- current active Blepharitis
- Oral Doxycyclines use
- Oral Antihistamine use
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Microsurgical Eye Institute
Boynton Beach, Florida, 33426
About this study
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.
- Conditions
- Dry Eye
- Being tested
- PEG-400 based artificial tear, Systane
- 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.
PEG-400 based artificial tearDrug
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
SystaneDrug
Instill one drop in the randomized eye four times daily. Can be used more frequently if needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PEG-400 based artificial tear Receives: Drug: PEG-400 based artificial tear |
| 2 | Active comparator | Systane Receives: Drug: Systane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye Signs
Measured: 4 months
Secondary outcomes (1)
Visual Quality
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Investigators
- Barry Schechter, MD, Principal investigator, Florida Microsurgical Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622037
- Sponsor's protocol ID
- 5338
- Status last verified
- Feb 2010
- First submitted
- 13 Feb 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral, Masked Comparison of PEG-400 Based Artificial Tear and Systane for the Treatment of Dry Eye Signs, Symptoms and Visual Quality
- ClinicalTrials.gov ID
- NCT00622037
- Acronym / sponsor ID
- 5338
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Feb 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.
To evaluate and compare the effects of PEG-400 based artificial tear and Systane tears in mild-moderate dry eye patients. TBUT, Visual impact and subjective evaluations will be assessed in this month long trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PEG-400 based artificial tearPEG-400 based artificial tear |
| 2 | Active comparator | Drug: SystaneSystane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient reported dry eye symptoms (episodic, annoying, activity limiting), SES OD.
- Physician assessment of mild-moderate dry eye
- Patient willing to instill drops QID and complete entire length of protocol.
- TBUT < 10 seconds
- BCVA of 20/30 or better
Key exclusion criteria (8 listed)
- Current topical cyclosporine use (Restasis)
- Current Systane use
- Refractive surgery within the last 6 months
- Oral or topical corticosteroid use
- Severe dry eye patients by physician assessment
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 |
|---|---|---|
| PEG-400 based artificial tearInstill one drop in the randomized eye four times daily. Can be used more frequently if needed | Drug | 1 |
| SystaneInstill one drop in the randomized eye four times daily. Can be used more frequently if needed | Drug | 2 |
Primary outcome
Dry Eye Signs
Time frame: 4 months
1 secondary outcome
Visual Quality
Time frame: 4 months
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 3 Feb 2010.
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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.
Barry Schechter, MD principal investigator
Florida Microsurgical Eye Institute
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 PEG-400 based artificial tear and Systane in people with Dry Eye, run by Bp Consulting, Inc 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 5 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 3 Feb 2010. 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?
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?
Dry Eye Signs (time frame: 4 months). 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 3 Feb 2010.