Dry Eye SyndromesPhase 4NCT01382810
Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
A Phase 4 study testing Altaire Gel forming solution and Refresh Tears in people with Dry Eye Syndromes, run by Innovative Medical at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients. 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 Syndromes
- What is being tested?
- Altaire Gel forming solution and Refresh Tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Oct 2012
- 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
- Patients 18 years or older.
- Males or females.
- Patient reported dry eye symptoms (episodic, annoying, activity limiting).
- Physician assessment of mild-moderate dry eye.
- Patient willing to instill drops TID and complete entire length of protocol.
- TBUT _< 10 seconds.
- At least Grade 6 Corneal Staining.
Who cannot join
- Current topical cyclosporine use (Restasis)
- Current Refresh use.
- Refractive surgery within the last 6 months.
- Oral or topical corticosteroid use.
- Severe dry eye patients by physician assessment.
- Current active blepharitis.
- Oral doxycycline use.
- Oral antihistamine use.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Jackson Eye, SC
Lake Villa, Illinois
Annie Christensen, 951-653-5566, a.christensen@imedsonline.com
Mitch Jackson, MD
- Recruiting
Koch Eye Associates
Warwick, Rhode Island
Annie Christensen, 951-653-5566, a.christensen@imedsonline.com
Paul Koch, MD
About this study
Official title: A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.
- Conditions
- Dry Eye Syndromes
- Being tested
- Altaire Gel forming solution, Refresh Tears
- Keywords
- dry eye signs and symptoms
- 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.
Altaire Gel forming solutionDrug
Three times a day for two months
Refresh TearsDrug
Three times a day for two months
| Study group | Role | What they receive |
|---|---|---|
| Altaire Gel forming solution | Active comparator | Not described Receives: Drug: Altaire Gel forming solution |
| Refresh Tears | Placebo comparator | Not described Receives: Drug: Refresh Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBUT
Test performed that measures how long the tears take to break up
Measured: 2 months
Conjunctival and Corneal staining
Dye that will be placed inside the eye to evaluate the surface of the ey
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382810
- Sponsor's protocol ID
- Altaire2011
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2011
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
- ClinicalTrials.gov ID
- NCT01382810
- Acronym / sponsor ID
- Altaire2011
- Conditions
- Dry Eye Syndromes
- Keywords
- dry eye signs and symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 27 Jun 2011 (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 and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Altaire Gel forming solution | Active comparator | Drug: Altaire Gel forming solution |
| Refresh Tears | Placebo comparator | Drug: Refresh Tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years or older.
- Males or females.
- Patient reported dry eye symptoms (episodic, annoying, activity limiting).
- Physician assessment of mild-moderate dry eye.
- Patient willing to instill drops TID and complete entire length of protocol.
Key exclusion criteria (8 listed)
- Current topical cyclosporine use (Restasis)
- Current Refresh 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 |
|---|---|---|
| Altaire Gel forming solutionThree times a day for two months | Drug | Altaire Gel forming solution |
| Refresh TearsThree times a day for two months | Drug | Refresh Tears |
Primary outcome
TBUT
Time frame: 2 months
Test performed that measures how long the tears take to break up
Conjunctival and Corneal staining
Time frame: 2 months
Dye that will be placed inside the eye to evaluate the surface of the ey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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.
2 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 Altaire Gel forming solution and Refresh Tears in people with Dry Eye Syndromes, run by Innovative Medical at 2 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 7 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: status not confirmed, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Contact Jenna Piel (951-653-5566, j.piel@imedsonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBUT (time frame: 2 months). The study lists 2 primary outcomes in all. 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 14 Jun 2012.