Atopic ConjunctivitisPhase 3NCT00884585
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
A Phase 3 study testing Cyclosporine 0.010% in people with Atopic Conjunctivitis, run by Allergan at 12 sites in 12 countries.
Trial summary
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Conjunctivitis
- What is being tested?
- Cyclosporine 0.010%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 12 sitesin 12 countries
- Study dates
- May 2009to Jul 2011
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
- Be on stable doses of your current AKC medications for at least 2 weeks
Who cannot join
- You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
- You are pregnant, breastfeeding, or planning to become pregnant during the study
- You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
- Conditions
- Atopic Conjunctivitis
- Being tested
- Cyclosporine Vehicle, Cyclosporine 0.010%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine VehicleDrug
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Cyclosporine 0.010%Drug
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine Ophthalmic Solution (COS) followed by COS | Experimental | Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. Receives: Drug: Cyclosporine 0.010% |
| Placebo followed by COS | Other | Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. Receives: Drug: Cyclosporine Vehicle; Drug: Cyclosporine 0.010% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Responders
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
Measured: Baseline, Month 2
Secondary outcomes (3)
Percentage of Punctate Corneal Staining Responders
Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
Measured: Month 2
Percentage of Patients With an Improvement in the Composite Symptom Score
Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.
Measured: Baseline, Month 2
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
Measured: Baseline, Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionJul 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 Atopic ConjunctivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884585
- Sponsor's protocol ID
- 192371-016
- Status last verified
- Nov 2012
- First submitted
- 17 Apr 2009
- Last updated
- 5 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT00884585
- Acronym / sponsor ID
- 192371-016
- Conditions
- Atopic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 5 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine Ophthalmic Solution (COS) followed by COS | Experimental | Drug: Cyclosporine 0.010%Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. |
| Placebo followed by COS | Other | Drug: Cyclosporine Vehicle, Drug: Cyclosporine 0.010%Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
- Be on stable doses of your current AKC medications for at least 2 weeks
Key exclusion criteria (3 listed)
- You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
- You are pregnant, breastfeeding, or planning to become pregnant during the study
- You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
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 VehiclePlacebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. | Drug | Placebo followed by COS |
| Cyclosporine 0.010%Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. | Drug | Cyclosporine Ophthalmic Solution (COS) followed by COS, Placebo followed by COS |
Primary outcome
Percentage of Treatment Responders
Time frame: Baseline, Month 2
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
3 secondary outcomes
Percentage of Punctate Corneal Staining Responders
Time frame: Month 2
Percentage of Patients With an Improvement in the Composite Symptom Score
Time frame: Baseline, Month 2
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Time frame: Baseline, Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- 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
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine 0.010% in people with Atopic Conjunctivitis, run by Allergan at 12 sites in 12 countries.
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 3 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 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Canada, Czechia, France and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Nov 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?
Percentage of Treatment Responders (time frame: Baseline, Month 2). 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 5 Nov 2012.