Conjunctivitis, AllergicPhase 4NCT00655109
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis
A Phase 4 study testing Olopatadine, Fluticasone and Saline in people with Conjunctivitis, Allergic, run by Greiner, Jack V., OD DO PhD at 1 site in United States.
Trial summary
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- Olopatadine, Fluticasone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2008
- Phase
- Phase 4
- 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
- At least 18 years of age \& either sex, any race
- Willing and able to follow all instructions and attend all study visits
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Who cannot join
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy, or lactating
- Use of disallowed medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Research Associates, Inc
North Andover, Massachusetts, 01845
About this study
Official title: A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis
Read the detailed description
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- Olopatadine, Fluticasone, Saline, Artificial tears
- Keywords
- Allergic conjunctivitis, Allergic rhinoconjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlopatadineDrug
Ophthalmic solution
FluticasoneDrug
Nasal spray
SalineDrug
Nasal spray
Artificial tearsDrug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Olopatadine Receives: Drug: Olopatadine |
| 2 | Active comparator | Fluticasone Receives: Drug: Fluticasone |
| 3 | Placebo comparator | Placebo nasal spray Receives: Drug: Saline |
| 4 | Placebo comparator | Placebo Eyedrops Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching
Measured: Minutes following CAC
Secondary outcomes (1)
Ocular redness
Measured: Minutes following CAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greiner, Jack V., OD DO PhD
- Investigators
- Jack V Greiner, OD, DO, PhD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655109
- Sponsor's protocol ID
- 08-003-04
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00655109
- Acronym / sponsor ID
- 08-003-04
- Conditions
- Conjunctivitis, Allergic
- Keywords
- Allergic conjunctivitis, Allergic rhinoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Greiner, Jack V., OD DO PhD
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Apr 2008 (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.
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis
Detailed description
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: OlopatadineOlopatadine |
| 2 | Active comparator | Drug: FluticasoneFluticasone |
| 3 | Placebo comparator | Drug: SalinePlacebo nasal spray |
| 4 | Placebo comparator | Drug: Artificial tearsPlacebo Eyedrops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age \& either sex, any race
- Willing and able to follow all instructions and attend all study visits
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Key exclusion criteria (3 listed)
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy, or lactating
- Use of disallowed medications
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 |
|---|---|---|
| OlopatadineOphthalmic solution | Drug | 1 |
| FluticasoneNasal spray | Drug | 2 |
| SalineNasal spray | Drug | 3 |
| Artificial tearsOphthalmic Solution | Drug | 4 |
Primary outcome
Ocular itching
Time frame: Minutes following CAC
1 secondary outcome
Ocular redness
Time frame: Minutes following CAC
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 Apr 2008.
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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.
Jack V Greiner, OD, DO, PhD principal investigator
ORA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olopatadine, Fluticasone and Saline in people with Conjunctivitis, Allergic, run by Greiner, Jack V., OD DO PhD 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 4 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 9 Apr 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 itching (time frame: Minutes following CAC). 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 Apr 2008; AzTrials last refreshed its copy on 8 Nov 2026.