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

Phase 3

Completed

• Conditions: Other conjunctivitis,

• Registration Number: CTRI/2018/09/015810
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This is A Phase III, Multicenter, Comparative, Randomized, Double blind, Two arm, Parallel group Clinical Study to evaluate Efficacy and Safety of Fixed  dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.

**Primary Objective**: To evaluate the efficacy of fixed dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.

**Secondary Objective**: To evaluate the safety of fixed dose combination of Alcaftadine 0.25% w/v and Ketorolac Tromethamine 0.4% w/v Eye Drops compared with Alcaftadine Ophthalmic Solution 0.25% w/v for the treatment of Subjects with Ocular Itching associated with Allergic Conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-25
• Study Completion: 2019-02-23
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• 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).
• 4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

• 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.
• 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.
• 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 randomization	At the end of Day 28

Secondary Outcome Measures

Name	Time	Method
Change in conjunctival hyperemia grade from baseline at all visits after randomization.	Change in Tearing score from baseline at all visits after randomization.

Trial Locations

Locations (16)

Arneja Heart and Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

B. J Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Chandulal Chandrakar Memorial Medical College & Hospital; 🇮🇳 Durg, CHHATTISGARH, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

J P M Rotary Club of Cuttack Eye Hospital & Research Institute; 🇮🇳 Cuttack, ORISSA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

L V Prasad Eye Institute; 🇮🇳 Khordha, ORISSA, India

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Arneja Heart and Multispeciality Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Ajay Kartik Ambade

Principal investigator

919823178466

dr_ajayambade@rediffmail.com