A study of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis
- Conditions
- Health Condition 1: null- Ocular Itching associated with Allergic conjunctivitisHealth Condition 2: H108- Other conjunctivitis
- Registration Number
- CTRI/2018/09/015810
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 222
1.Male or female subjects, aged 18 years to 65 years (both inclusive).
2.Treatment naïve subjects with diagnosis of ocular itching associated with allergic conjunctivitis (primary outcome measure).
3.Subjects willing to discontinue contact lens wear for at least 72 hours prior to screening visit and throughout the study.
4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
1.Subjects with Giant Papillary Conjunctivitis (GPC) will be excluded from the study.
2.Subjects with Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes
3.Subjects with presence of ocular infection (bacterial, viral or fungal) or history of ocular herpes within 3 months of screening visit.
4.Subjects with chronic ocular degenerative condition or active intraocular inflammation that could worsen during the study.
5.Subjects with known case of persistent dry eye syndrome or currently on treatment for dry eyes.
6.Subjects with known case of corneal epithelial detachment, corneal ulcer, Keratitis and evidence of corneal epithelial breakdown etc.
7.Subjects with known case of glaucoma will be excluded from the study.
8.Subjects with known case of ocular surgery within 6 months or scheduled to undergo ocular surgery during the study period.
9.Subjects planned to use contact lenses in the study eye during the study period.
10.Subjects with Visual acuity of 20/80 in any eye.
11.Subjects with Type 1 diabetes or Type 2 diabetes mellitus with HbA1c value greater than 8% within last 3 month prior to screening will be excluded from the study.
12.Subjects with known case of diabetic retinopathy.
13.Subjects with known case of clinically significant trauma to the study eye within the past 12 months.
14.Subjects who are blind or subjects with single eye will be excluded from the study.
15.Subjects with active peptic ulcer disease, gastrointestinal bleeding or perforation, or known history of peptic ulcer disease or gastrointestinal bleeding or any other bleeding disorders.
16.Clinically relevant recent (within 6 months of baseline visit) history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of the Investigational product.
17.Subjects with 1 month prior to screening visit or current use of systemic, topical or ocular corticosteroids, NSAIDs, anticholinergics, immunosuppressants, or H1-antihistamines.
18.Any contraindications or hypersensitivities to the use of the study medication or their components.
19.History of alcohol abuse and smoking.
20.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
21.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
22.Suspected inability or unwillingness to comply with the study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in ocular itching score from baseline at all visits after randomizationTimepoint: At the end of Day 28
- Secondary Outcome Measures
Name Time Method Change in conjunctival hyperemia grade from baseline at all visits after randomization. <br/ ><br>Change in Tearing score from baseline at all visits after randomization. <br/ ><br>Change in Chemosis score from baseline at all visits after randomization. <br/ ><br>Assessment of study medications by Subjects and Investigators at end of study visit. <br/ ><br>Timepoint: At the end of Day 28