Allergic ConjunctivitisPhase 2NCT00833495
Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation
A Phase 2 study testing Prednisolone Acetate 0.12% (Pred Mild®), FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) in people with Allergic Conjunctivitis, run by Fovea Pharmaceuticals SA at 1 site in United States.
Trial summary
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Prednisolone Acetate 0.12% (Pred Mild®), FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;
Who cannot join
- active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing
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 Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
- FOV1101-00 concentration 1 and Pred Mild®
- FOV1101-00 concentration 2 and Pred Mild®
- Vehicle of FOV1101-00 and Pred Forte®
- Vehicle of FOV1101-00 and Vehicle of FOV1101-00
- Conditions
- Allergic Conjunctivitis
- Being tested
- Prednisolone Acetate 0.12% (Pred Mild®), FOV1101-00, Prednisolone Acetate 1% (Pred Forte®), 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.
Prednisolone Acetate 0.12% (Pred Mild®)Drug
Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.
FOV1101-00Drug
This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.
Prednisolone Acetate 1% (Pred Forte®)Drug
PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.
PlaceboDrug
The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®) Receives: Drug: Prednisolone Acetate 0.12% (Pred Mild®); Drug: FOV1101-00 |
| 2 | Experimental | FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®) Receives: Drug: Prednisolone Acetate 0.12% (Pred Mild®); Drug: FOV1101-00 |
| 3 | Experimental | Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) Receives: Drug: Prednisolone Acetate 1% (Pred Forte®); Drug: Placebo |
| 4 | Placebo comparator | Vehicle of FOV1101-00 and vehicle of FOV1101-00 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Allergic signs and symptoms Diary Scores
Measured: Between V2 and V3
Secondary outcomes (1)
Various ocular and nasal allergic diary scores
Measured: Between V2 and V3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fovea Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Combal, PharmD, Study director, Fovea Pharmaceuticals SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833495
- Sponsor's protocol ID
- 08-003-27
- Status last verified
- Mar 2012
- First submitted
- 30 Jan 2009
- 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 Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation
- ClinicalTrials.gov ID
- NCT00833495
- Acronym / sponsor ID
- 08-003-27
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Fovea Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Feb 2009 (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.
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
- FOV1101-00 concentration 1 and Pred Mild®
- FOV1101-00 concentration 2 and Pred Mild®
- Vehicle of FOV1101-00 and Pred Forte®
- Vehicle of FOV1101-00 and Vehicle of FOV1101-00
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Prednisolone Acetate 0.12% (Pred Mild®), Drug: FOV1101-00FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®) |
| 2 | Experimental | Drug: Prednisolone Acetate 0.12% (Pred Mild®), Drug: FOV1101-00FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®) |
| 3 | Experimental | Drug: Prednisolone Acetate 1% (Pred Forte®), Drug: PlaceboVehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) |
| 4 | Placebo comparator | Drug: PlaceboVehicle of FOV1101-00 and vehicle of FOV1101-00 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;
Key exclusion criteria (1 listed)
- active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing
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 |
|---|---|---|
| Prednisolone Acetate 0.12% (Pred Mild®)Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. | Drug | 1, 2 |
| FOV1101-00This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day. | Drug | 1, 2 |
| Prednisolone Acetate 1% (Pred Forte®)PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. | Drug | 3 |
| PlaceboThe vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00. | Drug | 3, 4 |
Primary outcome
Ocular Allergic signs and symptoms Diary Scores
Time frame: Between V2 and V3
1 secondary outcome
Various ocular and nasal allergic diary scores
Time frame: Between V2 and V3
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.
Jean-Philippe Combal, PharmD study director
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 Prednisolone Acetate 0.12% (Pred Mild®), FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) 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 1 inclusion and 1 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?
Ocular Allergic signs and symptoms Diary Scores (time frame: Between V2 and V3). 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.