Seasonal Allergic Conjunctivitis to RagweedPhase 2NCT01287338
A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
A Phase 2 study testing Olopatadine in people with Seasonal Allergic Conjunctivitis to Ragweed, run by Mati Therapeutics Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Conjunctivitis to Ragweed
- What is being tested?
- Olopatadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jan 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of allergic conjunctivitis to ragweed for at least one year
- Positive skin prick test to ragweed pollen within 12 months prior to visit 1
- BCVA of at leat 20/400
Who cannot join
- Structural lid abnormalities (ectropion, entropion)
- Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
- Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
- History of ophthalmic abnormality, including a history of dry eye
- Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
- History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
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- presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
- Currently on any chronic ocular topical medications
- Use of topical or systemic ocular medications during the study period
- History of complications, adverse events, trauma or disease in the nasolacrimal area
- History of symptomatic epiphoria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.
- Being tested
- Olopatadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlopatadineDrug
low dose
OlopatadineDrug
high dose
| Study group | Role | What they receive |
|---|---|---|
| Lower Puncta Delivery | Experimental | Not described Receives: Drug: Olopatadine |
| Double Puncta Delivery | Experimental | Not described Receives: Drug: Olopatadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
Measured: 4 Days
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
Measured: 4 days
Secondary outcomes (1)
Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms
Measured: 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Lack of definitive clinical results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic Conjunctivitis to RagweedStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dipak Panigrahi, MD, Study director, QLT Inc.Deepen Patel, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287338
- Sponsor's protocol ID
- PP0 AC 01
- Other IDs
- 141741
- Status last verified
- Sep 2013
- First submitted
- 27 Jan 2011
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
- ClinicalTrials.gov ID
- NCT01287338
- Acronym / sponsor ID
- PP0 AC 01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of definitive clinical results.
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Feb 2011 (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 test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.
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 |
|---|---|---|
| Lower Puncta Delivery | Experimental | Drug: Olopatadine |
| Double Puncta Delivery | Experimental | Drug: Olopatadine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of allergic conjunctivitis to ragweed for at least one year
- Positive skin prick test to ragweed pollen within 12 months prior to visit 1
- BCVA of at leat 20/400
Key exclusion criteria (11 listed)
- Structural lid abnormalities (ectropion, entropion)
- Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
- Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
- History of ophthalmic abnormality, including a history of dry eye
- Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
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 |
|---|---|---|
| Olopatadinelow dose | Drug | Lower Puncta Delivery |
| Olopatadinehigh dose | Drug | Double Puncta Delivery |
Primary outcome
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
Time frame: 4 Days
Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
Time frame: 4 days
1 secondary outcome
Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms
Time frame: 4
Results and safety
The study was stopped early (reason given: Lack of definitive clinical results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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.
Dipak Panigrahi, MD study director
QLT Inc.
Deepen Patel, MD principal investigator
Cetero Research, San Antonio
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 Olopatadine in people with Seasonal Allergic Conjunctivitis to Ragweed, run by Mati Therapeutics Inc. at 1 site in Canada.
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 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: stopped early, as of the sponsor's last update on 17 Sep 2013. 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 Canada. 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?
The study was stopped early (reason given: Lack of definitive clinical results.). Results are not available in the source record.
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?
Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed (time frame: 4 Days). The study lists 2 primary outcomes in all. 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 17 Sep 2013.