A bioequivalance study comparing Tobradex eye drops of Alcon pharma with study medication with same combination of Cipla in aqueous humor of patients undergoing cataract surgery.

Not yet recruiting

• Conditions: Bilateral cataracts undergoing indicated cataract surgery

• Registration Number: CTRI/2015/10/006326
• Lead Sponsor: Cipla Ltd

Brief Summary

Study Title: A Multi Center, Open Label, Randomized, Two-Treatment, In Vivo, Crossover, Single Dose, Bioequivalence Study with Pharmacokinetic Endpoints to Compare the Pharmacokinetics of Marketed Product TobraDex® (Containing Tobramycin 0.3% and Dexamethasone 0.1 % Ophthalmic Suspension, Manufactured by Alcon Laboratories, Inc., USA) to an Investigational Ophthalmic Sterile Suspension (Containing Tobramycin 0.3% and Dexamethasone 0.1%, Manufactured by Cipla Limited, India), in Aqueous Humor of Patients Undergoing Indicated Cataract Surgery.

Sample size:36

Study population: Patients with bilateral cataract

Primary Objective:

The objective of this study is to evaluate the bioequivalence of the test product, Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension with the reference listed drug, TobraDex® ophthalmic suspension in aqueous humor of patients undergoing indicated cataract surgery.

For this purpose, the pharmacokinetic (PK) profile of dexamethasone in aqueous humor will be determined and compared after administration of a single dose of each of the two drugs.

Secondary objectives:

1. To monitor the safety and tolerability of a single dose of the test drug and the reference drug in patients undergoing indicated cataract surgery

2. Sample size determination for the pivotal study

5 Visits:

V1: Screening (30 days prior to Day 1)

V2: (Day 1): Surgery of first eye

V3: (Within day 7): Post-operative follow up visit

V4: (Within Day 35 after first eye surgery): Surgery of second eye

V5: (Within 7 days after second eye surgery): Follow up visit to assess the second operated eye and safety evaluation of both eyes

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-11
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

(1) Men or non-pregnant women of 18 to 65 years of age (2)Presence of visually significant cataracts in both eyes as established by the complete ophthalmologic exam which are accounting for a best corrected visual acuity of 20/40 or worse as measured on Snellen chart or with glare (3) Have a chief complaint consistent with visually significant cataracts such as but not limited to halos and/or glare with vision, difficulty reading, ambulating and or walking (4) Be medically fit with clinically acceptable laboratory profiles (5) Be willing to follow the required pre operative directions and post op care and be able to follow the scheduled appointment (6) Have given the written informed consent for participation in the study.

Exclusion Criteria

• (1) Participation in any ophthalmic indicative bioavailability/ bioequivalence/ Pharmacokinetic study or received an ophthalmic indicative investigational drug within a period of three months prior to screening (2) Pregnant women or lactating mothers or women planning to become pregnant during the study period (3) Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva (4) History of “recent (last 15 days)†or “active†viral diseases of the cornea and conjunctiva.
• Presence of corneal conditions like but not limited to Keratoconus, Fuch’s Dystrophy, S/P PKP, Chronic corneal erosion/ulcers/edema, S/P refractive surgery (5) Presence or history of uveitis or uveitis within the previous 12 months, or laser-assisted in-situ keratomileusis, photorefractive, keratectomy, radial keratotomy, or similar surgery in the previous three months (6) Presence of retinal disorders including but not limited to glaucoma, active diabetic retinopathy, wet/ dry macular degeneration, Histoplasmosis and any other retinal disease that would make vision worse than 20/50 best corrected will be excluded (7) Ocular trauma within past three months of the screening, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption (8) Patients who had received topical and or systemic/ oral steroids including but not limited to dexamethasone or beclomethasone within 7 days of screening (9) History of any allergies (e.g. asthma, urticaria) including drug allergies that would place the patient at increased risk, as determined by the investigator(s) (10) Known hypersensitivity or allergy to TobraDex® in combination or its components (11) History of alcohol, chemical, drug abuse or dependence (12) Serologic positivity for the Hepatitis B virus (HBsAg) and Human Immunodeficiency Virus (HIV 1 and 2) (13) Presence of clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system or psychiatric disease or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the patient at increased risk, as determined by the investigator(s).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this study is to evaluate the bioequivalence of the test product, Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension with the reference listed drug, TobraDex® ophthalmic suspension in aqueous humor of patients undergoing indicated cataract surgery.	Pharmacokinetic (PK) profile of dexamethasone in aqueous humor will be determined and compared after administration of a single dose of each of the two drugs

Secondary Outcome Measures

Name	Time	Method
(1) To monitor the safety and tolerability of a single dose of the test drug and the reference drug in patients undergoing indicated cataract surgery	(2) Sample size determination for the pivotal study

Trial Locations

Locations (3)

Kempe Gowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

M and J Institute of Ophthalmology; 🇮🇳 Ahmadabad, GUJARAT, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Kempe Gowda Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Sowbhagya H N

Principal investigator

09620937759

drhnsowbhagyaappaji@gmail.com