Health Condition 1: H101- Acute atopic conjunctivitis Health Condition 2: null- ALLERGIC CONJUNCTIVITIS
Conditions
Interventions
Intervention1: ALCAFTADINE 0.25% OPHTHALMIC SOLUTION: 2 DROPS IN AFFECTED EYE ONCE A DAY IN THE MORNING FOR 21 DAYS
Control Intervention1: OLOPATADINE 0.1% OPHTHALMIC SOLUTION: 2 DROPS IN AFFECTED EYE
Sponsors
Dr M Karthiga
Eligibility
Inclusion criteria
Inclusion criteria: 1)All patients aged > 18 years of both genders clinically diagnosed with allergic conjunctivitis by ophthalmologists. 2)Graded conjunctival redness in at least one region (nasal or temporal) in Eye. 3)Graded ocular itching at any one time point 4)Visual acuity of at least 6/15 in each eye 5)All patients who had an attack history more than 2 years
Exclusion criteria
Exclusion criteria: 1)Patients with bacterial, chlamydial, viral and membranous conjunctivitis were excluded 2)Patients with ocular surface disorders like pterygium, dry eye were excluded from the study. 3)Patients who have known hypersensitivity to the drug. 4)History of uveitis, blepharitis, herpes simplex keratitis or herpes zoster keratitis. 5)History of retinal detachment, diabetic retinopathy and progressive retinal disease 6)History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year. 7)Ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial. 8)Use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit. 9)Participants unwilling not to wear contact lenses during the study. 10)Pregnant and lactating women 11)Subjects must not have an ocular itching score >0 or a conjunctival hyperaemia score >1 in either eye in any region (nasal or temporal) at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To compare the improvement in ocular symptoms and signs in patients with Allergic conjunctivitis after the treatment with the study drugs. 2) To compare the reduction in levels of IgE in tear fluid in patients of Allergic Conjunctivitis after the treatment with both the drugs. Timepoint: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean of ocular itching and redness as assessed after 30 minutes of instillation of drops Change from baseline in mean of ocular symptoms and signs on 8th day Changes in Quality of Life as measured by Allergic Rhinoconjunctivitis Quality of Life QuestionnaireTimepoint: 3 weeks | — |
Countries
India
Contacts
Public ContactDr M Karthiga
Sri Ramachandra Medical College and Research Institute
Outcome results
None listed