Allergic ConjunctivitisPhase 3NCT01363700
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
A Phase 3 study testing DE-114 ophthalmic solution and Olopatadine Hydrochloride 0.1% Ophthalmic Solution in people with Allergic Conjunctivitis, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- DE-114 ophthalmic solution and Olopatadine Hydrochloride 0.1% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 64 years
- All sexes
- Adult
Who may be able to join
- Provided signed, written informed consent.
- Has a positive result from an allergen-specific IgE antibody test.
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Who cannot join
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- DE-114 ophthalmic solution, Placebo ophthalmic solution, Olopatadine Hydrochloride 0.1% Ophthalmic Solution
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-114 ophthalmic solutionDrug
Also called Epinastine ophthalmic solution
Placebo ophthalmic solutionDrug
Olopatadine Hydrochloride 0.1% Ophthalmic SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DE-114 ophthalmic solution |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo ophthalmic solution |
| 3 | Active comparator | Not described 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.
Mean Ocular Itching Score Compared to Placebo Period1
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.
The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Measured: Visit 5 (3, 5, and 10 minutes post-CAC)
Mean Hyperemia Score Compared to Placebo Period1
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.
The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
Measured: Visit 5 (5, 10, and 20 minutes post-CAC)
Secondary outcomes (2)
Mean Ocular Itching Score Compared to Olopatadine Period2
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.
The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Measured: Visit 7 (3, 5, and 10 minutes post-CAC)
Mean Hyperemia Score Compared to Olopatadine Period2
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.
The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
Measured: Visit 7 (5, 10, and 20 minutes post-CAC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363700
- Sponsor's protocol ID
- 01141101
- Status last verified
- Nov 2014
- First submitted
- 30 May 2011
- Last updated
- 19 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.
PubMed 25163405
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
- ClinicalTrials.gov ID
- NCT01363700
- Acronym / sponsor ID
- 01141101
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Jun 2012 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Posted 5 Nov 2014
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 the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients with allergic conjunctivitis.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DE-114 ophthalmic solution |
| 2 | Placebo comparator | Drug: Placebo ophthalmic solution |
| 3 | Active comparator | Drug: Olopatadine Hydrochloride 0.1% Ophthalmic Solution |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provided signed, written informed consent.
- Has a positive result from an allergen-specific IgE antibody test.
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Key exclusion criteria (2 listed)
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
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 |
|---|---|---|
| DE-114 ophthalmic solutionAlso: Epinastine ophthalmic solution | Drug | 1 |
| Placebo ophthalmic solution | Drug | 2 |
| Olopatadine Hydrochloride 0.1% Ophthalmic Solution | Drug | 3 |
Primary outcome
Mean Ocular Itching Score Compared to Placebo Period1
Time frame: Visit 5 (3, 5, and 10 minutes post-CAC)
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge .
Mean Hyperemia Score Compared to Placebo Period1
Time frame: Visit 5 (5, 10, and 20 minutes post-CAC)
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge .
2 secondary outcomes
Mean Ocular Itching Score Compared to Olopatadine Period2
Time frame: Visit 7 (3, 5, and 10 minutes post-CAC)
Mean Hyperemia Score Compared to Olopatadine Period2
Time frame: Visit 7 (5, 10, and 20 minutes post-CAC)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25163405Fujishima H, Ohashi Y, Takamura E. Efficacy of epinastine hydrochloride ophthalmic solution in allergic conjunctivitis by conjunctival cedar pollen allergen challenge. Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.
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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.
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 3 study testing DE-114 ophthalmic solution and Olopatadine Hydrochloride 0.1% Ophthalmic Solution in people with Allergic Conjunctivitis, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
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 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 19 Nov 2014. 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 Japan. 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 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?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Ocular Itching Score Compared to Placebo Period1 (time frame: Visit 5 (3, 5, and 10 minutes post-CAC)). 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?
On the ClinicalTrials.gov record for NCT01363700, 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 19 Nov 2014.