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Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

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Alcon

Status and phase

Completed
Phase 4

Conditions

Allergic Conjunctivitis

Treatments

Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01109485
JPN-P-2010-1

Details and patient eligibility

About

The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.

Enrollment

42 patients

Sex

All

Ages

7 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients whose parents or guardians can issue informed consent
  • Patients aged over 7 and less than 16 at the baseline
  • Patients confirmed to show type I allergy
  • Patients with allergic conjunctivitis
  • Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)

Exclusion criteria

  • Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
  • Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
  • Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
  • Patients having received continuous treatment with corticosteroid within 3 months
  • Patients having received immunotherapy
  • Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
  • Patients having undergone ocular laser therapy within 3 months
  • Unilaterally blind patients (best corrected visual acuity: below 0.01)
  • Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
  • Patients necessitating the use of contact lens during the study period
  • Other patients judged by the attending physician as inappropriate for study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

Olopatadine
Experimental group
Description:
Olopatadine hydrochloride ophthalmic solution 0.1%
Treatment:
Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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