Health Condition 1: null- Patients with Allergic Conjunctivitis
Conditions
Interventions
Intervention1: Pataday ( Olopatadine 0.2% ): Once Daily for 7 days
Intervention2: Pataday 0.2%: Pts will be dosed on Pataday eye drops once daily for 7 days in this open label single arm study
Sponsors
Alcon India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects 18 years of age or older. Subjects may be of either sex and of any race. Subjects must be able to read, understand and answer survey questions. Willing and able to make all required study visits, and follow directions as stipulated by the protocol and investigator. History (within the past 24 months) of allergic conjunctivitis. Subjects with active signs and symptoms of ocular allergies for which treatment is necessary. Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug. Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
Exclusion criteria
Exclusion criteria: Contraindications or hypersensitivity to the use of the study medication or its components [e.g., benzalkonium chloride (BAC), disodium EDTA, and povidone]. Inability or unwillingness to follow all study instructions and complete study visits as required. Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit. A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye) Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination. Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study. Presumed or actual ocular infection (bacterial, viral, or fungal) or history of ocular herpes in either eye as determined by subject history and/or examination. Any severe or serious ocular condition or other medical condition that could result in a patient?s inability to safely complete the study. Any significant illness (history or current) that could be expected to interfere with the study including autoimmune disease, psoriasis, eczema, rosacea, severe cardiovascular disease including clinically significant arrhythmias, poorly controlled hypertension, poorly controlled diabetes, history of status asthmaticus, or history of moderate to severe allergic asthma. Chronic or intermittent use of intranasal, inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids. Chronic use of long acting antihistamines (oral or intranasal). Inability to discontinue contact lens wear for each of the study visits, at the time of study medication instillation, and for ten minutes following instillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate subject perceptions of olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the patients as a part of this post marketing surveillance studyTimepoint: Decrease in Allergic Conjunctivitis | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public Contactmr Mangesh Chaudhary
Alcon Labs Pvt Ltd
Outcome results
None listed