Dry Eye SyndromesPhase 1NCT01319773

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

A Phase 1 study testing cyclosporine ophthalmic emulsion Formulation A, cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine… 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?: cyclosporine ophthalmic emulsion Formulation A, cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Jan 2011
Phase: Phase 1
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Parallel-Group Phase:
Weigh at least 110 lbs
18 to 45 years old
Paired-Eye Phase:
Dry eye disease in both eyes

Who cannot join

Parallel-Group Phase:
Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
Has donated blood within 90 days
Significant weight change (over 10 lbs) within 60 days
Previous use of RESTASIS®
Parallel-Group and Paired-Eye Phases:

Show all 11Show fewer

Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
Consumption of alcohol products within 72 hours
Paired-Eye Phase:
Previous ocular surgery
Use of RESTASIS® within 30 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Newport Beach, California

Other trials in United States

About this study

Conditions: Dry Eye Syndromes
Being tested: cyclosporine ophthalmic emulsion Formulation A, cyclosporine ophthalmic emulsion Formulation B, cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%, cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%, cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B
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.

cyclosporine ophthalmic emulsion Formulation ADrug
One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.
cyclosporine ophthalmic emulsion Formulation BDrug
One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%Drug
Also called RESTASIS®
One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%Drug
Also called RESTASIS®
One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation BDrug
One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.

Study groups in NCT01319773
Study group	Role	What they receive
cyclosporine ophthalmic emulsion Formulation A (Formulation A)	Experimental	Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A Receives: Drug: cyclosporine ophthalmic emulsion Formulation A
cyclosporine ophthalmic emulsion Formulation B (Formulation B)	Experimental	PGP: cyclosporine ophthalmic emulsion Formulation B Receives: Drug: cyclosporine ophthalmic emulsion Formulation B
Formulation A and cyclosporine ophthalmic emulsion 0.05%	Other	Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05% Receives: Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
Formulation B and cyclosporine ophthalmic emulsion 0.05%	Other	PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05% Receives: Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
Formulation A and Formulation B	Experimental	PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B Receives: Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
Measured: Day 1

Secondary outcomes (2)

Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).
Measured: 3 Days
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jan 2011

First posted22 Mar 2011 (estimated)
Study startNov 2010
Primary completionJan 2011
Study completionJan 2011

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 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01319773
Sponsor's protocol ID: 192371-021
Status last verified: Aug 2015
First submitted: 18 Mar 2011
Last updated: 7 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
ClinicalTrials.gov ID: NCT01319773
Acronym / sponsor ID: 192371-021
Conditions: Dry Eye Syndromes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 22 Mar 2011 (estimated)
Results: Posted 2 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
cyclosporine ophthalmic emulsion Formulation A (Formulation A)	Experimental	Drug: cyclosporine ophthalmic emulsion Formulation AParallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
cyclosporine ophthalmic emulsion Formulation B (Formulation B)	Experimental	Drug: cyclosporine ophthalmic emulsion Formulation BPGP: cyclosporine ophthalmic emulsion Formulation B
Formulation A and cyclosporine ophthalmic emulsion 0.05%	Other	Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
Formulation B and cyclosporine ophthalmic emulsion 0.05%	Other	Drug: cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
Formulation A and Formulation B	Experimental	Drug: cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation BPEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Weigh at least 110 lbs
18 to 45 years old
Dry eye disease in both eyes

Key exclusion criteria (11 listed)

Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
Has donated blood within 90 days
Significant weight change (over 10 lbs) within 60 days
Previous use of RESTASIS®
Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days

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
cyclosporine ophthalmic emulsion Formulation AOne drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.	Drug	cyclosporine ophthalmic emulsion Formulation A (Formulation A)
cyclosporine ophthalmic emulsion Formulation BOne drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.	Drug	cyclosporine ophthalmic emulsion Formulation B (Formulation B)
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%Also: RESTASIS®One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.	Drug	Formulation A and cyclosporine ophthalmic emulsion 0.05%
cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%Also: RESTASIS®One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.	Drug	Formulation B and cyclosporine ophthalmic emulsion 0.05%
cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation BOne drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.	Drug	Formulation A and Formulation B

Primary outcome

Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
Time frame: Day 1
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.

2 secondary outcomes

Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
Time frame: 3 Days
Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
Time frame: Day 1

Results and safety

Results posted to the registry on 2 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PGP: Cyclosporine Formulation A	10	10
PGP: Cyclosporine Formulation B	10	10
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%	8	8
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%	8	8
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B	8	8

Primary outcome: Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)

Time frame: Day 1. Number. Unit: Nanogram/milliliter (ng/mL)

Measure	Cyclosporine Formulation A n = 10	Cyclosporine Formulation B n = 10
Time = pre-dose	NA	NA
Time = 0.5 hours	NA	NA
Time = 1 hour	NA	NA
Time = 3 hours	NA	NA

Population analysed: Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PGP: Cyclosporine Formulation A	0 of 10 (0%)	4 of 10 (40%)	Not reported
PGP: Cyclosporine Formulation B	0 of 10 (0%)	2 of 10 (20%)	Not reported
PEP: Cyclosporine Formulation A and Cyclosporine 0.05%	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
PEP: Cyclosporine Formulation B and Cyclosporine 0.05%	0 of 8 (0%)	8 of 8 (100%)	Not reported
PEP: Cyclosporine Formulation A and Cyclosporine Formulation B	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 7 Sep 2015. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 2 Mar 2012). 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?

Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01319773.

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 7 Sep 2015.