Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
Detailed description
Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug. A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.
Interventions
DRUGPRO-118
instill one drop in each eye once a day for 21 days
instill one drop in each eye once a day for 21 days
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Provide informed consent * Allergic conjunctivitis diagnosis * Both genders * Age between 6 and 60 years * Patients with no treatment 2 years prior to study inclusion
Exclusion criteria
* Patients with one blind eye * Visual acuity \< 20/40 in any eye * Patients with any active ocular disease that would interfere with study interpretation * Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol * Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer * Patients with history of hypersensitivity or contraindication for any drug used in the study * Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators * Pregnant patients, at risk of pregnancy or breastfeeding * Patients without birth control treatment * Patients who had participated in any clinical trial in the last 90 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| conjunctival hyperemia | day 21 | Change from Baseline in conjunctival hyperemia after 21 days of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| epiphora | day 21 | Change from Baseline in epiphora after 21 days of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| green lissamine dye | day 21 | Number of patients with normal green lissamine dye |
| fluorescein dye | day 21 | Number of patients with normal fluorescein dye |
Outcome results
None listed