Health Condition 1: null- Positive history of active seasonal allergic conjunctivitis or perennial Allergic conjunctivitis (Over 1 year) or Rhinoconjunctivitis as Judged by the Investigator
Conditions
Interventions
Intervention1: LP010-09: LP010-09 is a herbal ophthalmic formulation (Ayurvedic)
Two drops twice daily will be administered to the patients.
Intervention2: LP010-09: LP010-09 is a herbal ophthalmic formulation (Ayurvedic)
Single dose once daily will be administered to the patients.
Control Intervention1: Olopatadine eye drops: Anti-Histamine and mast cell stabilizer used for the treatment of allergic conjunctivitis
Sponsors
Laila Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Positive history of active seasonal allergic conjunctivitis (Over past few weeks) or perennial Allergic conjunctivitis (Over 1 year) or Rhinoconjunctivitis as Judged by the Investigator • Willing and able to follow all instructions and adhere to the study protocol and come for the specified follow ups • If on any other medication, willing to stop its use for at least 15 days before commencement.
Exclusion criteria
Exclusion criteria: • Have planned surgery during trial period • Have ocular infections, or ocular conditions that could affect study parameters as per the investigatorâ??s judgement • Patency of lacrimal duct impaired • Have used an investigational drug or device as a part of another study within past 30 days • Ocular Discomfort Score less than 5 or greater than 12 • Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use two proven methods of contraception during and for at least 2 weeks following the final dose of study drug. • Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrolment into the study • History of severe asthma, reactive airway disease or bronchial obstruction • Ocular surgery or trauma in the last year. • Known contraindications or sensitivities to the study medication or its components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total ocular symptoms score in 4 point scale of 0 to 3Timepoint: Day 0, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to day 7 if any in the levels of IgE in tear samples.Timepoint: Day 0 and Day 7;Patientâ??s global evaluation of allergic conjunctivitis; Physicianâ??s global evaluation of allergic conjunctivitis Timepoint: Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactDr C N Ramchand
Laila Pharmaceuticals Pvt. Ltd.,
Outcome results
None listed