A clinical Trial in patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Clinical trial is to study efficacy, safety and tolerability of Moxifloxacin plus Bromfenac eye drops in comparison to Gatifloxacin plus Dexamethasone eye drops.
- Conditions
- Ocular pain,
- Registration Number
- CTRI/2010/091/000280
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
This study is a Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Moxifloxacin 0.5% w/v + Bromfenac 0.09% w/v 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. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures will be assessed by Slit Lamp Biomicroscopy at day 1, Day 3, Day 5 and Day 7. The secondary outcome measures will be assessed by Conjunctival hyperaemia, corneal and lid oedema, Ocular Infection, pain, photophobia and tearing at day 1, Day 3, Day 5 and Day 7.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- Patients who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery at the same time) 2.
- Written informed consent to participate to the trial.
- Patients < 18 & > 60 years.2. Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs; 3.
- Patients who underwent local injection of corticosteroids 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) 4.
- Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs; 5.
- 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); 6.
- Patients who underwent preoperative and/or postoperative intravitreous injection of corticosteroids; 7.
- Patients who underwent sub-conjunctival injection 8.
- Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations; 9.
- Patients who underwent gas tamponade at the surgery; 10.
- Patients with endogenous uveitis; 11.
- Patients having corneal epithelial detachment or corneal ulcer in the target eye; 12.
- Patients who have allergy to corticosteroid drugs; 13.
- Patients who are required to wear contact lens during the study period; 14.
- Patients who are scheduled to undergo surgery of the opposite eye during the study period; 15.
- Patients who are pregnant or may be pregnant or lactating; 16.
- 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 Biomicroscopy Day 1,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 Day 1,Day 3, Day 5 and Day 7.
Trial Locations
- Locations (3)
Dr. Sharad Mistrys Clinic
🇮🇳Thane, MAHARASHTRA, India
Murlidhar Nursing and Maternity Home
🇮🇳Thane, MAHARASHTRA, India
Nakshatra Netralaya
🇮🇳Latur, MAHARASHTRA, India
Dr. Sharad Mistrys Clinic🇮🇳Thane, MAHARASHTRA, IndiaDr Sharad MistryPrincipal investigator09821711054esmile1614@yahoo.co.in