MedDataX Logo

Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

NCT ID: NCT01363700

Last Updated: 2014-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Conjunctivitis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

DE-114 ophthalmic solution

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

3

Group Type ACTIVE_COMPARATOR

Olopatadine Hydrochloride 0.1% Ophthalmic Solution

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DE-114 ophthalmic solution

Intervention Type DRUG

Placebo ophthalmic solution

Intervention Type DRUG

Olopatadine Hydrochloride 0.1% Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epinastine ophthalmic solution

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Santen study sites

Osaka, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25163405 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01141101

Identifier Type: -

Identifier Source: org_study_id