Dry Eye SyndromesPhase 4NCT00284999
Soothe Versus Refresh
A Phase 4 study testing Soothe and Refresh Tears in people with Dry Eye Syndromes, run by Pharmaceutical Research Network at 3 sites in United States.
Trial summary
To determine the ocular efficacy and safety of Soothe and Refresh Tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Soothe and Refresh Tears
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Aug 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with a diagnosis of dry eyes
- Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
- a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test
Who cannot join
- contact lens use during the active treatment periods of the trial
- history of Sjogren's Syndrome
- temporary punctal occlusion that is still effective
- the current or anticipated use during the study of punctual plugs
- current treatment with Restasis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Coastal Research Associates, LLC
Atlanta, Georgia, 30339
Mount Sinai School of Medicine
New York, New York, 10029-6574
Michigan Cornea Associates
Southfield, Michigan, 48034
About this study
To determine the ocular efficacy and safety of Soothe and Refresh Tears.
- Conditions
- Dry Eye Syndromes
- Being tested
- Soothe, Refresh Tears
- 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.
SootheDrug
Refresh TearsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Pharmaceutical Research Network
- Sponsor type
- University, hospital or other
- Investigators
- William C. Stewart, MD, Study director, Pharmaceutical Research Network, LLCPenny Asbell, MD, Principal investigator, Icahn School of Medicine at Mount SinaiChristopher Chow, MD, Principal investigator, Michigan Cornea AssociatesDouglas G. Day, MD, Principal investigator, Coastal Research Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284999
- Sponsor's protocol ID
- PRN 05-034
- Status last verified
- Aug 2006
- First submitted
- 31 Jan 2006
- Last updated
- 22 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soothe Versus Refresh
- ClinicalTrials.gov ID
- NCT00284999
- Acronym / sponsor ID
- PRN 05-034
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Pharmaceutical Research NetworkUniversity, hospital or other
- Study completion
- Aug 2006
- First posted
- 1 Feb 2006 (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 determine the ocular efficacy and safety of Soothe and Refresh Tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with a diagnosis of dry eyes
- Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
- a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test
Key exclusion criteria (5 listed)
- contact lens use during the active treatment periods of the trial
- history of Sjogren's Syndrome
- temporary punctal occlusion that is still effective
- the current or anticipated use during the study of punctual plugs
- current treatment with Restasis
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 |
|---|---|---|
| Soothe | Drug | – |
| Refresh Tears | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Aug 2006.
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A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
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Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
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A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
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.
William C. Stewart, MD study director
Pharmaceutical Research Network, LLC
Penny Asbell, MD principal investigator
Icahn School of Medicine at Mount Sinai
Christopher Chow, MD principal investigator
Michigan Cornea Associates
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soothe and Refresh Tears in people with Dry Eye Syndromes, run by Pharmaceutical Research Network at 3 sites 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 3 inclusion and 5 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 22 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 22 Aug 2006; AzTrials last refreshed its copy on 30 Oct 2026.