Dry Eye SyndromesPhase 2NCT02013791
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
A Phase 2 study testing Cyclosporine New Ophthalmic Formulation in people with Dry Eye Syndromes, run by Allergan at 8 sites in United States.
Trial summary
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. 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?
- Cyclosporine New Ophthalmic Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Apr 2014to 12 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Moderate to severe dry eye disease in both eyes
- Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
Who cannot join
- Use of any cyclosporine preparations within 3 months
- Use of topical medications, other than artificial tears, in the eyes within 1 month
- Use of contact lenses in either eye within 1 month
- Stage 2 only: Participation in Stage 1 of this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Sall Research Medical Center
Artesia, California, 90701
Johns Hopkins University - Wilmer Eye Institute
Baltimore, Maryland, 21287
Vision Institute
Colorado Springs, Colorado, 80907
Lugene Eye Institute
Glendale, California, 91204
Lakeside Vision Center
Irvine, California, 92604
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142
Steve Yoelin MD Medical Asscociates
Newport Beach, California, 92663
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
Official title: A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
- Conditions
- Dry Eye Syndromes
- Being tested
- Vehicle, Sham, Cyclosporine New Ophthalmic Formulation
- 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.
VehicleDrug
Vehicle of cyclosporine administered as per protocol
ShamOther
Sham administered to non-study eye as per protocol on Day 1
Cyclosporine New Ophthalmic FormulationDrug
Also called RESTASIS® X
Cyclosporine New Ophthalmic Formulation administered as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Cohort 1 | Other | Vehicle administered to study eye and Sham administered to non-study eye on Day 1. Receives: Drug: Vehicle; Other: Sham |
| Stage 1 Cohort 2 | Experimental | Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 3 | Experimental | Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 4 | Experimental | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 5A | Experimental | Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 6A | Experimental | Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 6B | Experimental | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 6C | Experimental | Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
| Stage 1 Cohort 6D | Experimental | Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. Receives: Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Measured: First dose of study drug to up to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start29 Apr 2014
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleonora Safyan, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013791
- Sponsor's protocol ID
- 192371-024
- Status last verified
- Apr 2018
- First submitted
- 12 Dec 2013
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02013791
- Acronym / sponsor ID
- 192371-024
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 15 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Cohort 1 | Other | Drug: Vehicle, Other: ShamVehicle administered to study eye and Sham administered to non-study eye on Day 1. |
| Stage 1 Cohort 2 | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1. |
| Stage 1 Cohort 3 | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1. |
| Stage 1 Cohort 4 | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1. |
| Stage 1 Cohort 5A | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1. |
| Stage 1 Cohort 6A | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1. |
| Stage 1 Cohort 6B | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1. |
| Stage 1 Cohort 6C | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
| Stage 1 Cohort 6D | Experimental | Drug: Vehicle, Drug: Cyclosporine New Ophthalmic FormulationCyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe dry eye disease in both eyes
- Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
Key exclusion criteria (4 listed)
- Use of any cyclosporine preparations within 3 months
- Use of topical medications, other than artificial tears, in the eyes within 1 month
- Use of contact lenses in either eye within 1 month
- Stage 2 only: Participation in Stage 1 of this study
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 |
|---|---|---|
| VehicleVehicle of cyclosporine administered as per protocol | Drug | Stage 1 Cohort 1, Stage 1 Cohort 2, Stage 1 Cohort 3, Stage 1 Cohort 4, Stage 1 Cohort 5A, Stage 1 Cohort 6A, Stage 1 Cohort 6B, Stage 1 Cohort 6C, Stage 1 Cohort 6D |
| ShamSham administered to non-study eye as per protocol on Day 1 | Other | Stage 1 Cohort 1 |
| Cyclosporine New Ophthalmic FormulationAlso: RESTASIS® XCyclosporine New Ophthalmic Formulation administered as per protocol | Drug | Stage 1 Cohort 2, Stage 1 Cohort 3, Stage 1 Cohort 4, Stage 1 Cohort 5A, Stage 1 Cohort 6A, Stage 1 Cohort 6B, Stage 1 Cohort 6C, Stage 1 Cohort 6D |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose of study drug to up to 24 Weeks
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eleonora Safyan study director
Allergan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine New Ophthalmic Formulation in people with Dry Eye Syndromes, run by Allergan at 8 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: First dose of study drug to up to 24 Weeks). 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 15 May 2018.