A clinical Trial in patients with inflammatory ocular conditions. Clinical trial is to study efficacy, safety and tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops in comparison to Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops.

Phase 3

Completed

• Conditions: Other specified inflammations of eyelid,

• Registration Number: CTRI/2010/091/001136
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a Comparative, Randomized, single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in 100 patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Date of first enrollment will be 23 August 2010.

The primary outcome measures will be Slit Lamp Biomicroscopic Examination at day 0, Day 3, Day 5 and Day 7. The secondary outcome measures will be Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as: 0 = Nil, 1 = Mild, 2 = Moderate, 3= Severe at day 0, Day 3, Day 5 and Day 7.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-23
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
• 2.Patients showing an anterior chamber cell score of not less than 2 at a day after surgery.
• 3.Written informed consent to participate to the trial.

Exclusion Criteria

• 1.Patients < 18 & > 60 years.2.Patients who took systemic administration of corticosteroids or immunosuppressive agents in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded.
• 3.Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs; 4.Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery); 5.Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids; 6.Patients who underwent sub-conjunctival injection7.Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations; 8.Patients who underwent gas tamponade at the surgery; 9.Patients with endogenous uveitis; 10.Patients having corneal epithelial detachment or corneal ulcer in the target eye; 11.Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye; 12.Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents; 13.Patients showing IOP not less than 25 mmHg a day after surgery; 14.Patients who have allergy to corticosteroid drugs; 15.Patients who are required to wear contact lens during the study period; 16.Patients who are scheduled to undergo surgery of the opposite eye during the study period; 17.Patients who are pregnant or may be pregnant or lactating; 18.Patients who have participated in other clinical studies within 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Slit Lamp Biomicroscopic Examination	Day 0, Day 3, Day 5 and Day 7.

Secondary Outcome Measures

Name	Time	Method
Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as 0 Nil, 1 Mild, 2 Moderate, 3 Severe.	Day 0, Day3, Day 5 and Day 7.

Trial Locations

Locations (3)

Divya jyot eye hospital,; 🇮🇳 Mahesana, GUJARAT, India

Dr. Sharad Mistry's Clinic; 🇮🇳 Thane, MAHARASHTRA, India

The Baroda association for the blind,; 🇮🇳 Vadodara, GUJARAT, India

Divya jyot eye hospital,

🇮🇳Mahesana, GUJARAT, India

Dr Nimisha Patel

Principal investigator

09825192139

dr.bhavesh_patel@yahoo.co.in