Allergic ConjunctivitisPhase 2NCT01120132
Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
A Phase 2 study testing CsA high dose, CsA low dose and PA in people with Allergic Conjunctivitis, run by Fovea Pharmaceuticals SA at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- CsA high dose, CsA low dose and PA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 716 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2010
- 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
- history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
- visual acuity score ≥ 0.60 (EDTS)
- negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.
Who cannot join
- active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
- contraindications or known allergies to the study drug(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation
The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- CsA high dose, CsA low dose, PA, Placebo
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CsA high doseDrug
Solution of Cyclosporine (high dose) administered during 28 days
CsA low doseDrug
Solution of Cyclosporine (low dose) administered during 28 days
PADrug
Suspension of Prednisolone Acetate administered during 28 days
PlaceboDrug
Placebo solution administered during 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine low dose , Prednisolone Acetate | Experimental | Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate Receives: Drug: CsA low dose; Drug: PA |
| Cyclosporine high dose, Prednisolone Acetate | Experimental | Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate Receives: Drug: CsA high dose; Drug: PA |
| Cyclosporine high dose | Experimental | Administration of a solution of Cyclosporine (high dose) and Placebo Receives: Drug: CsA high dose; Drug: Placebo |
| Cyclosporine low dose | Experimental | Administration of a solution of Cyclosporine (low dose) and Placebo Receives: Drug: CsA low dose; Drug: Placebo |
| Prednisolone Acetate | Active comparator | Administration of a suspension of Prednisolone Acetate and Placebo Receives: Drug: PA |
| Placebo | Placebo comparator | Administration of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary assessment of signs and symptoms of ocular allergy
Patient-reported ocular itching and redness
Measured: During the 28 days of treatment
Secondary outcomes (2)
Diary and office assessments of various ocular and nasal allergy signs and symptoms
Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching
Investigator assessments of ocular redness and chemosis
Measured: During 28 days of treatment
Safety
Ocular tolerance and adverse events
Measured: During the 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fovea Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Louise Jacques, MD MBA, Study chair, Fovea Pharmaceuticals SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120132
- Sponsor's protocol ID
- FOV1101/CLIN202
- Other IDs
- 10-003-03
- Status last verified
- Mar 2012
- First submitted
- 29 Apr 2010
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation
- ClinicalTrials.gov ID
- NCT01120132
- Acronym / sponsor ID
- FOV1101/CLIN202
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- Fovea Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 May 2010 (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 efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine low dose , Prednisolone Acetate | Experimental | Drug: CsA low dose, Drug: PAAdministration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate |
| Cyclosporine high dose, Prednisolone Acetate | Experimental | Drug: CsA high dose, Drug: PAAdministration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate |
| Cyclosporine high dose | Experimental | Drug: CsA high dose, Drug: PlaceboAdministration of a solution of Cyclosporine (high dose) and Placebo |
| Cyclosporine low dose | Experimental | Drug: CsA low dose, Drug: PlaceboAdministration of a solution of Cyclosporine (low dose) and Placebo |
| Prednisolone Acetate | Active comparator | Drug: PAAdministration of a suspension of Prednisolone Acetate and Placebo |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
- visual acuity score ≥ 0.60 (EDTS)
- negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.
Key exclusion criteria (2 listed)
- active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
- contraindications or known allergies to the study drug(s)
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 |
|---|---|---|
| CsA high doseSolution of Cyclosporine (high dose) administered during 28 days | Drug | Cyclosporine high dose, Cyclosporine high dose, Prednisolone Acetate |
| CsA low doseSolution of Cyclosporine (low dose) administered during 28 days | Drug | Cyclosporine low dose, Cyclosporine low dose , Prednisolone Acetate |
| PASuspension of Prednisolone Acetate administered during 28 days | Drug | Cyclosporine high dose, Prednisolone Acetate, Cyclosporine low dose , Prednisolone Acetate, Prednisolone Acetate |
| PlaceboPlacebo solution administered during 28 days | Drug | Cyclosporine high dose, Cyclosporine low dose, Placebo |
Primary outcome
Diary assessment of signs and symptoms of ocular allergy
Time frame: During the 28 days of treatment
Patient-reported ocular itching and redness
2 secondary outcomes
Diary and office assessments of various ocular and nasal allergy signs and symptoms
Time frame: During 28 days of treatment
Safety
Time frame: During the 28 days of treatment
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 9 Mar 2012.
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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.
Marie-Louise Jacques, MD MBA study chair
Fovea Pharmaceuticals SA
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 CsA high dose, CsA low dose and PA in people with Allergic Conjunctivitis, run by Fovea Pharmaceuticals SA 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 3 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 9 Mar 2012. 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?
Diary assessment of signs and symptoms of ocular allergy (time frame: During the 28 days of treatment). 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 9 Mar 2012.