Allergic ConjunctivitisPhase 3NCT00331500
Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis
A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2006to 27 Jul 2006
- Phase
- Phase 3
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model
Who cannot join
- Under 10 years of age
About this study
Official title: A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, Olopatadine Hydrochloride Ophthalmic Solution Vehicle
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Drug
Olopatadine Hydrochloride Ophthalmic Solution VehicleDrug
Inactive ingredients used as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine Hydrochloride 0.2% | Experimental | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% |
| Vehicle | Placebo comparator | Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily ocular itching and redness scores
Measured: Up to Day 14
Secondary outcomes (1)
Percentage of patients with daily ocular itching and redness scores of 0
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study start18 Apr 2006
- Primary completion27 Jul 2006
- Study completion27 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon, A Novartis Company, Study director, Alcon, a Novartis Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331500
- Sponsor's protocol ID
- C-04-60
- Status last verified
- Jun 2008
- First submitted
- 30 May 2006
- Last updated
- 14 Aug 2017
- Results posted
- No
Publications
https://www.ncbi.nlm.nih.gov/pubmed/23379201
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00331500
- Acronym / sponsor ID
- C-04-60
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2006 (actual)
- Primary completion
- 27 Jul 2006 (actual)
- Study completion
- 27 Jul 2006 (actual)
- First posted
- 31 May 2006 (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 demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.
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 |
|---|---|---|
| Olopatadine Hydrochloride 0.2% | Experimental | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks |
| Vehicle | Placebo comparator | Drug: Olopatadine Hydrochloride Ophthalmic Solution VehicleOlopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model
Key exclusion criteria (1 listed)
- Under 10 years of age
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 |
|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution, 0.2% | Drug | Olopatadine Hydrochloride 0.2% |
| Olopatadine Hydrochloride Ophthalmic Solution VehicleInactive ingredients used as a placebo comparator | Drug | Vehicle |
Primary outcome
Daily ocular itching and redness scores
Time frame: Up to Day 14
1 secondary outcome
Percentage of patients with daily ocular itching and redness scores of 0
Time frame: Up to Day 14
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 14 Aug 2017.
- Results publicationhttps://www.ncbi.nlm.nih.gov/pubmed/23379201
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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.
Alcon, A Novartis Company study director
Alcon, a Novartis Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution, 0.2% in people with Allergic Conjunctivitis, run by Alcon Research.
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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Daily ocular itching and redness scores (time frame: Up to Day 14). 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 NCT00331500, which also lists 1 linked publication.
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 14 Aug 2017.