Disease ProgressionPhase 4NCT00567983
Topical Cyclosporine and Disease Progression
A Phase 4 study testing Restasis and Endura in people with Disease Progression and Disease Severity, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease Progression, Disease Severity, Staining
- What is being tested?
- Restasis and Endura
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 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
- Mild to Moderate dry eye symptoms
Who cannot join
- Current use of Restasis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.
- Conditions
- Disease Progression, Disease Severity, Staining, Schirmers, OSDI
- Being tested
- Restasis, Endura
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestasisDrug
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
EnduraDrug
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1. | Active comparator | Not described Receives: Drug: Restasis |
| 2. | Placebo comparator | Not described Receives: Drug: Endura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity
Measured: 1 yr
Secondary outcomes (1)
Staining
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease ProgressionStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sanjay Rao, Principal investigator, Lakeside Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567983
- Sponsor's protocol ID
- 13717A
- Status last verified
- Sep 2008
- First submitted
- 3 Dec 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cyclosporine and Disease Progression
- ClinicalTrials.gov ID
- NCT00567983
- Acronym / sponsor ID
- 13717A
- Conditions
- Disease Progression, Disease Severity, Staining, Schirmers, OSDI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 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.
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.
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 |
| 2. | Placebo comparator | Drug: Endura |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to Moderate dry eye symptoms
Key exclusion criteria (1 listed)
- Current use of 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 |
|---|---|---|
| RestasisRestasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily | Drug | 1. |
| EnduraRestasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily | Drug | 2. |
Primary outcome
Disease Severity
Time frame: 1 yr
1 secondary outcome
Staining
Time frame: 1 yr
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 25 Sep 2008.
Related trials for Disease Progression
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
Not yet recruitingPhase 1/2
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1
Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
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.
Sanjay Rao principal investigator
Lakeside Eye Clinic
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 and Endura in people with Disease Progression and Disease Severity, 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 1 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 25 Sep 2008. 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?
Disease Severity (time frame: 1 yr). 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 25 Sep 2008.