A Clinical Study to test the Effectiveness, Safety and Tolerance of Alcaftadine eye drops in comparison with Olopatadine hydrochloride eye drops in patients who are suffering from Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Unspecified disorder of conjunctiva,

• Registration Number: CTRI/2015/11/006338
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a Comparative, Randomized, Double Blind, Parallel groupand Non Crossover Multicentric Clinical Study with Alcaftadine eye drops or Olopatadinehydrochloride eye drops in Subjects Suffering from Allergic Conjunctivitis.

Ocular allergies are very common and range in intensity from mild, self-resolving, acute conditions to serious, chronic disease that can severely affect vision.

 The efficacy parameter is primarilyfocused on ocular itching and conjuctival redness.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Study Completion: 2016-05-25
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• The study will be conducted in 2 stages: In 1st stage subjects between 18 to 60 years (both inclusive) will be enrolled.
• Based on the outcome of 1st stage of the study and its report submitted to the committee, in the 2nd stage, study will be conducted on 10 to less than 18 years age group of subjects.
• Subjects with diagnosis of allergic conjunctivitis.
• Freshly diagnosed or subject who are previously diagnosed and on treatment of Allergic conjunctivitis will undergo washout period for 3 days.
• Voluntary willingness of patient to give written as well as Audio-Visual informed consent prior to participation in clinical trial.
• For Minor subject LAR (Legally Acceptable Representative) should be taken with assent form.

Exclusion Criteria

• Male and female subjects <10 years and >60 years of age.
• Women who were not using an effective means of contraception or who are pregnant or nursing.
• Visual acuity of 20/40 in any eye.
• Subject who are blind or subject with single eye.
• Subject with history of active stage of any other concomitant ocular disease.
• Contraindication or sensitivity to any component of study treatment.
• Subject having history of chronic use of ocular medication other than the study drug, progressive or functionally visual field loss within the past year.
• Contact lens user.
• Subject who are schedule to undergo surgery of the eye during the study period.
• Subject with known history of ocular inflammation or any other condition that in the opinion of the investigator that does not justify the patient’s participation in the study.
• Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
• Subject not willing to comply with the study protocol and provide written informed consent to participation.
• Any disease or condition that could interfere with the safety and efficacy evaluation of the study medication.
• Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
• Subject with Schirmer<10 should be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Alcaftadine Vs. Olopatadine hydrochloride eye drops in Subjects Suffering from Allergic Conjunctivitis.	Day 0, At the end of 3rd Day, At the end of 7th Day, At the end of 14th Day

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of Alcaftadine Vs. Olopatadine hydrochloride eye drops.	Global assessment of study medications by Subjects and Investigators.

Trial Locations

Locations (9)

Arneja Heart & Multispecialty Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Institute of Post Graduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

King George’s Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Regional Institute of Ophthalmology; 🇮🇳 Kolkata, WEST BENGAL, India

Seth G.S. Medical College & K.E.M Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

SR Kalla Memorial Gastro and General Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Arneja Heart & Multispecialty Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Ajay Ambade

Principal investigator

09823178466

drajaya.cicrs@gmail.com