Health Condition 1: H108- Other conjunctivitis
Conditions
Interventions
Intervention1: Arm A: Cetirizine Hydrochloride IP (Eq. to Cetirizine 0.24% w/v): Arm A: Cetirizine Hydrochloride IP (Eq. to Cetirizine 0.24% w/v). Instill one drop twice daily (approximately 8 hours a
Sponsors
AKUMS DRUGS PHARMACEUTICALS LTD
AKUMS DRUGS PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1 Aged between 18 years to 75 years of both gender 2 Patient with signs and symptoms of allergic conjunctivitis diagnosed clinically 3 Subjects must have an ocular itching score 0 4 Patient is willing to give informed consent able to provide availability for the entire study period and follow study protocol
Exclusion criteria
Exclusion criteria: Patients with bacterial chlamydial viral and membranous conjunctivitis Patients with ocular surface disorders like pterygium dry eye were excluded from the study. Patients with history of uveitis blepharitis herpes simplex keratitis or herpes zoster keratitis. Patients with history of retinal detachment diabetic retinopathy and progressive retinal disease Patients with history of glaucoma or Intraocular Pressure over 25mmHg at the screening visit, or a history of elevated IOP within the past 1year. Patients with ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial. Patients with use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit. Patients unwilling not to wear contact lenses during the study. Pregnant and lactating women Patient with history of hereditary degenerative retinal disorders eg retinitis pigmentosa or ischemic optic neuropathy including nonarteritic anterior ischemic optic neuropathy Patient with history of bleeding disorders or significant active peptic ulceration Patient with history of cancer or undergoing cancer chemo or radiotherapy Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components; or history of hypersensitivity reaction to sulfa drugs Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study Investigator, study personnel, sponsor representatives and their first-degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ocular Itching Severity Score from baselineTimepoint: Time frame: Day 1 3rd Minute, Day 1 5th Minute, Day 1 7th Minute, Day 2, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the studyTimepoint: Time frame: Screening, Day 2, Day 7 & Day 14 | — |
Countries
India
Contacts
Public ContactBadrinath Sangle
Belagavi Institute of Medical Science
Outcome results
None listed