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Role of topical bromfenac sodium 0.09% in cataract surgery patients

Ocular Pharmacokinetics of Once Daily and Twice Daily Dosing of Topical Bromfenac Sodium 0.09% and its Outcomes in Cataract Surgery Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021909
Enrollment
60
Registered
2019-11-07
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: H251- Age-related nuclear cataract

Interventions

Intervention1: Bromfenac 0/09%: topical bromfenac 0.09% ophthalmic solution given as once daily and twice daily for 3 months Control Intervention1: not applicable: not applicable

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Senile Cataract

Exclusion criteria

Exclusion criteria: Ocular co-morbidity- active inflammation, glaucoma, corneal disorders or retinal pathology. History of any previous ocular surgery On any other topical ocular medication Systemic co-morbidity-Diabetes mellitus, collagen vascular diseases, heart disease, stroke etc Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Ocular pharmacokinetics of topical bromfenac 0.09% (once daily and twice daily dosing) Timepoint: stage 1- Samples will be taken during cataract surgery after 15 min, 30min, 1hr, 2hrs, 4hrs and 12 hrs after single drop of bromfenac 0.09% instillation stage 2 - samples will be collected after giving bromfenac 0.09% pre operatively for 5 days as once daily and twice daily

Secondary

MeasureTime frame
Pain score, intra-operative miosis, post-operative anterior chamber flare and central macular thickness Timepoint: day 1, day 7, 1 month, 3month

Countries

India

Contacts

Public ContactRajeswari Thangavel

All India Insitute of Ophthalmic Sciences

titiyal@gmail.com9810649942

Outcome results

None listed

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