Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery

NCT04022811 Phase 4 COMPLETED

To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1% dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision with amniotic membrane transplantation(AMT).

Details

Lead sponsor	Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase	Phase 4
Status	COMPLETED
Enrolment	60
Start date	2016-10
Completion	2017-10

Conditions

• Pterygium
• Pain

Interventions

• 0.1% bromfenac

Primary outcomes

• visual analog scale(VAS) — Change from Baseline VAS at 10 days
  The VAS pain score provides an intensity score of the pain experienced. The VAS allows the patient to self-rate his or her pain on a 0 to 10 horizontal grading scale of subjective pain assessment with 0 as "no pain at all" and 10 being "the most severe intolerable pain I have ever experienced."
• present pain intensity index(PPI) — Change from Baseline PPI at 10 days
  The PPI scale is a measure of the magnitude of pain experienced by an individual and is a six-point verbal rating scale that indicates overall pain intensity and includes six levels (0, none; 1, mild; 2, discomforting; 3, distressing; 4, horrible; and 5, excruciating). Higher numbers indicate more severe pain.

Countries

China