Seasonal Allergic ConjunctivitisPhase 2NCT01344083
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
A Phase 2 study testing T1210 and Olopatadine hydrochloride in people with Seasonal Allergic Conjunctivitis, run by Laboratoires Thea at 1 site in France.
Trial summary
The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Seasonal Allergic Conjunctivitis
- What is being tested?
- T1210 and Olopatadine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Feb 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Conjunctivitis allergic conjunctivitis
Who cannot join
- Severe ocular allergy
- Vernal keratoconjunctivitis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.
- Conditions
- Seasonal Allergic Conjunctivitis
- Being tested
- T1210, Olopatadine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1210Drug
2 drops T1210 once a day
Olopatadine hydrochlorideDrug
2 drops once a day Olopatadine
| Study group | Role | What they receive |
|---|---|---|
| T1210 | Experimental | Not described Receives: Drug: T1210 |
| Olopatadine hydrochloride | Active comparator | Not described Receives: Drug: Olopatadine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the score of tearing
Measured: Day 28
Change from baseline of the score of itching
Measured: Day 28
Change from baseline of the score of conjunctival hyperaemia
Measured: Day 28
Secondary outcomes (2)
Global local tolerance assessment by the Investigator and the patient
Measured: Day 7
Global local tolerance assessment by the Investigator and the patient
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344083
- Sponsor's protocol ID
- LT1210-PII-04/10
- Status last verified
- Apr 2011
- First submitted
- 21 Apr 2011
- Last updated
- 12 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01344083
- Acronym / sponsor ID
- LT1210-PII-04/10
- Conditions
- Seasonal Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 28 Apr 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 aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1210 | Experimental | Drug: T1210 |
| Olopatadine hydrochloride | Active comparator | Drug: Olopatadine hydrochloride |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Conjunctivitis allergic conjunctivitis
Key exclusion criteria (2 listed)
- Severe ocular allergy
- Vernal keratoconjunctivitis
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 |
|---|---|---|
| T12102 drops T1210 once a day | Drug | T1210 |
| Olopatadine hydrochloride2 drops once a day Olopatadine | Drug | Olopatadine hydrochloride |
Primary outcome
Change from baseline of the score of tearing
Time frame: Day 28
Change from baseline of the score of itching
Time frame: Day 28
Change from baseline of the score of conjunctival hyperaemia
Time frame: Day 28
2 secondary outcomes
Global local tolerance assessment by the Investigator and the patient
Time frame: Day 7
Global local tolerance assessment by the Investigator and the patient
Time frame: Day 28
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 12 Apr 2012.
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Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
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Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis
Allergic Conjunctivitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 T1210 and Olopatadine hydrochloride in people with Seasonal Allergic Conjunctivitis, run by Laboratoires Thea at 1 site in France.
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 2 inclusion and 2 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 12 Apr 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 France. 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 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?
Change from baseline of the score of tearing (time frame: Day 28). The study lists 3 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 12 Apr 2012.