Dry EyePhase 2NCT00814944
A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
A Phase 2 study testing Sirolimus in people with Dry Eye, run by Santen Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Oct 2009
- Phase
- Phase 2
- 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
- Have a reported history of dry eye in both eyes;
- Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months.
Who cannot join
- Have contraindications to the use of the study medications;
- Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Research Associates
Andover, Massachusetts, 01810
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called MS-R001, rapamycin
Subconjunctival injection of 440 micrograms sirolimus in each eye.
SirolimusDrug
Also called MS-R003, rapamycin
Subconjunctival injection of 220 micrograms sirolimus in each eye.
SirolimusDrug
Also called MS-R002, rapamycin
Subconjunctival injection of 880 micrograms sirolimus in each eye.
SirolimusDrug
Subconjunctival injection of placebo in each eye.
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Experimental | Not described Receives: Drug: Sirolimus |
| Dose Group 2 | Experimental | Not described Receives: Drug: Sirolimus |
| Dose Group 3 | Experimental | Not described Receives: Drug: Sirolimus |
| Dose Group 4 | Placebo comparator | Not described Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean corneal fluorescein staining (inferior region) after CAE exposure.
Measured: Day 28
Mean ocular discomfort during CAE exposure.
Measured: Day 28
Secondary outcomes (2)
Safety across treatment groups.
Measured: Through 28 days
Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionOct 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Responsible party
- Sponsor
- Investigators
- Joel Naor, MD, Study director, MacuSight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814944
- Sponsor's protocol ID
- DES-001
- Status last verified
- Jul 2010
- First submitted
- 23 Dec 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
- ClinicalTrials.gov ID
- NCT00814944
- Acronym / sponsor ID
- DES-001
- Conditions
- Dry Eye
- Keywords
- dry eye, sirolimus, rapamycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Collaborators
- MacuSight, Inc.
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Dec 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.
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Experimental | Drug: Sirolimus |
| Dose Group 2 | Experimental | Drug: Sirolimus |
| Dose Group 3 | Experimental | Drug: Sirolimus |
| Dose Group 4 | Placebo comparator | Drug: Sirolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a reported history of dry eye in both eyes;
- Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months.
Key exclusion criteria (2 listed)
- Have contraindications to the use of the study medications;
- Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;
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 |
|---|---|---|
| SirolimusAlso: MS-R001, rapamycinSubconjunctival injection of 440 micrograms sirolimus in each eye. | Drug | Dose Group 2 |
| SirolimusAlso: MS-R003, rapamycinSubconjunctival injection of 220 micrograms sirolimus in each eye. | Drug | Dose Group 1 |
| SirolimusAlso: MS-R002, rapamycinSubconjunctival injection of 880 micrograms sirolimus in each eye. | Drug | Dose Group 3 |
| SirolimusSubconjunctival injection of placebo in each eye. | Drug | Dose Group 4 |
Primary outcome
Mean corneal fluorescein staining (inferior region) after CAE exposure.
Time frame: Day 28
Mean ocular discomfort during CAE exposure.
Time frame: Day 28
2 secondary outcomes
Safety across treatment groups.
Time frame: Through 28 days
Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity.
Time frame: Day 28
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 10 Jan 2013.
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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.
Joel Naor, MD study director
MacuSight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus in people with Dry Eye, run by Santen 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 2 inclusion and 2 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 10 Jan 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean corneal fluorescein staining (inferior region) after CAE exposure. (time frame: Day 28). 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 10 Jan 2013.