Rhinitis, Allergic, SeasonalPhase 3NCT01258309
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
A Phase 3 study testing olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution and olopatadine hydrochloride 0.1% ophthalmic solution in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by Allergan at 1 site in India.
Trial summary
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
- What is being tested?
- olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution and olopatadine hydrochloride 0.1% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2010to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of seasonal allergic conjunctivitis
Who cannot join
- Ocular infection or history of ocular herpes infection
- History of retinal detachment or diabetic retinopathy
- Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
- Ocular surgery within 8 weeks
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
- Being tested
- olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution, olopatadine hydrochloride 0.1% ophthalmic solution
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solutionDrug
One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
olopatadine hydrochloride 0.1% ophthalmic solutionDrug
Also called Patanol®
One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution Receives: Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution |
| 2 | Active comparator | olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution Receives: Drug: olopatadine hydrochloride 0.1% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching
Measured: Day 21
Secondary outcomes (3)
Hyperemia
Measured: Day 21
Chemosis
Measured: Day 21
Ocular mucous discharge
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258309
- Sponsor's protocol ID
- Olo-keto/2009
- Status last verified
- Jan 2012
- First submitted
- 9 Dec 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01258309
- Acronym / sponsor ID
- Olo-keto/2009
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Dec 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.
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solutionolopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
| 2 | Active comparator | Drug: olopatadine hydrochloride 0.1% ophthalmic solutionolopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of seasonal allergic conjunctivitis
Key exclusion criteria (4 listed)
- Ocular infection or history of ocular herpes infection
- History of retinal detachment or diabetic retinopathy
- Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
- Ocular surgery within 8 weeks
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 /ketorolac tromethamine fixed dose combination ophthalmic solutionOne drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days. | Drug | 1 |
| olopatadine hydrochloride 0.1% ophthalmic solutionAlso: Patanol®One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days. | Drug | 2 |
Primary outcome
Ocular Itching
Time frame: Day 21
3 secondary outcomes
Hyperemia
Time frame: Day 21
Chemosis
Time frame: Day 21
Ocular mucous discharge
Time frame: Day 21
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 25 Jan 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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution and olopatadine hydrochloride 0.1% ophthalmic solution in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by Allergan at 1 site in India.
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 4 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 25 Jan 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 India. 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 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?
Ocular Itching (time frame: Day 21). 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 25 Jan 2012.