A Clinical Study to Assess the Efficacy and Safety of Cetirizine Ophthalmic Solutio
- Conditions
- Health Condition 1: H108- Other conjunctivitis
- Registration Number
- CTRI/2024/08/072453
- Lead Sponsor
- AKUMS DRUGS PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Ocular Itching Severity Score from baselineTimepoint: Time frame: Day 1 3rd Minute, <br/ ><br>Day 1 5th Minute, Day 1 7th Minute, Day 2, Day 7 and Day 14
- Secondary Outcome Measures
Name Time Method Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the studyTimepoint: Time frame: Screening, Day 2, Day 7 & Day 14