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.

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 patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000280

Enrollment

100

Registered

2010-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Health Condition 2: H571- Ocular pain

Interventions

Intervention1: Moxifloxacin 0.5% w/v + Bromfenac 0.09% eye drops: Instill 1 drop four times a day for 7 days Control Intervention1: Gatifloxacin 0.3% + Dexamathasone 0.1% eye drops: Instill 1 drop fou

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
Slit Lamp BiomicroscopyTimepoint: Day 1,Day 3, Day 5 and Day 7.	—

Secondary

Measure	Time frame
Conjunctival hyperaemia, corneal and lid oedema, Ocular Infection, pain, photophobia and tearingTimepoint: Day 1,Day 3, Day 5 and Day 7.	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026