Treatment of Dry Eye DiseasePhase 4NCT00567177
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
A Phase 4 study testing Restasis, Refresh Plus in people with Treatment of Dry Eye Disease, run by Innovative Medical at 1 site in United States.
Trial summary
We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment of Dry Eye Disease
- What is being tested?
- Restasis, Refresh Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Using computers more than three hours per day
- Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
- An abnormal confocal image of 5 or greater.
Who cannot join
- All corneal disorders except for tear disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hermann Eye Center
6400 Fannin Ste 1800, Texas, 77030
About this study
We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.
- Conditions
- Treatment of Dry Eye Disease
- Being tested
- Restasis, Refresh Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restasis, Refresh PlusDrug
Restasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Restasis, Refresh Plus |
| 2 | Placebo comparator | Not described Receives: Drug: Restasis, Refresh Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye disease
Measured: 6 months
Secondary outcomes (1)
efficacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startNov 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Dry Eye DiseaseStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Yee, MD, Principal investigator, Hermann Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567177
- Sponsor's protocol ID
- HSC-MS-07-0421
- Status last verified
- Jul 2010
- First submitted
- 30 Nov 2007
- Last updated
- 30 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease
- ClinicalTrials.gov ID
- NCT00567177
- Acronym / sponsor ID
- HSC-MS-07-0421
- Conditions
- Treatment of Dry Eye Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Dec 2007 (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.
We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.
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: Restasis, Refresh Plus |
| 2 | Placebo comparator | Drug: Restasis, Refresh Plus |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Using computers more than three hours per day
- Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
- An abnormal confocal image of 5 or greater.
Key exclusion criteria (1 listed)
- All corneal disorders except for tear disorders.
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 |
|---|---|---|
| Restasis, Refresh PlusRestasis 0.4ml- (in the eye) Instill one drop twice daily in morning and evening Refresh Plus 0.4ml- (in the eye) Instill one drop twice daily in morning and evening | Drug | 1, 2 |
Primary outcome
Dry Eye disease
Time frame: 6 months
1 secondary outcome
efficacy
Time frame: 6 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 30 Jul 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.
Richard Yee, MD principal investigator
Hermann Eye Center
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 Restasis, Refresh Plus in people with Treatment of Dry Eye Disease, run by Innovative Medical 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 3 inclusion and 1 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 Jul 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. 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?
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 disease (time frame: 6 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 30 Jul 2010.