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

Allergic Conjunctivitis Clinical Trial

Official title:

Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363700
• Other study ID #: 01141101
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2011
• Last updated: November 5, 2014

Study information

• Verified date: November 2014
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. primary completion date: June 2012
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• DE-114 ophthalmic solution

• Placebo ophthalmic solution

• Olopatadine Hydrochloride 0.1% Ophthalmic Solution

Locations

Country	Name	City	State
Japan	Santen study sites	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	Visit 5 (3, 5, and 10 minutes post-CAC)	No
Primary	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 .	Visit 5 (5, 10, and 20 minutes post-CAC)	No
Secondary	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 .	Visit 7 (3, 5, and 10 minutes post-CAC)	No
Secondary	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 .	Visit 7 (5, 10, and 20 minutes post-CAC)	No