Clinical trial NCT04022811: Effect of Bromfenac on Pain Related to Pterygium Surgery
Official title: Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pterygium
Pain
Keywords: Pterygium
Bromofenac
Pain
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Patients scheduled to undergo pterygium excision with AMT were randomized to receive added topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. Pain intensity was evaluated with the visual analog scale(VAS) and present pain index(PPI) with the short form of the McGill Pain Questionnaire. psychological state used Self-rating of Depression Scale(SDS) and Self-rating of Anxiety Scale (SAS) to assess. Ocular inflammation was assessed with an automated bulbar redness grading technique. The irritative symptoms evaluation was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS). Corneal epithelial healing rate was calculated after following up. All patients had follow-ups at the day 1, day 3, day7 and day 10.

Eligibility criteria: Inclusion criteria

1. Patients with unilateral or double pterygium
2. The gender is not limited, age 45-75 years old
3. intraocular pressure \<21mmHg
4. follow the preoperative and postoperative drug regimen and ensure regular follow-up

Exclusion Criteria

1. Patient factors: lack of cooperation and poor compliance.
2. Severe dry eye, Sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface.
3. Glaucoma or high intraocular pressure (above 21 mmHg), active uveitis, retinal detachment and other diseases.
4. History of systemic diseases, such as uncontrolled diabetes and hypertension, rosacea, severely impaired cardiopulmonary function or other diseases that cannot tolerate surgery; central nervous system disorders affect patient perception, trigeminal neuritis, trigeminal neuralgia, and tongue Pharyngeal neuralgia, migraine and period of toothache attack.
5. history of drug allergies, such as NSAID drugs, tobramycin, anesthetics and so on. Smokers and alcoholics (smoking volume \>15 cigarettes/day, pure alcohol consumption\>100 ml/week).
6. Other history of eye surgery, such as history of eye trauma, history of glaucoma surgery, history of cataract surgery, history of retinal surgery, or other serious injuries to the eyelids, conjunctiva, cornea, and other tissues of the eye surface.

Primary outcomes:
measure: visual analog scale(VAS)
timeFrame: Change from Baseline VAS at 10 days
measure: present pain intensity index(PPI)
timeFrame: Change from Baseline PPI at 10 days
Secondary outcomes:
measure: corneal epithelium healing(CEH)
timeFrame: Change from Baseline corneal epithelial defect at 10 days
measure: Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI)
timeFrame: Change from Baseline TCHI at 10 days
measure: Symptoms Evaluation by ocular symptom scores(OSS)
timeFrame: Change from Baseline OSS at 10 days
measure: psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS)
timeFrame: Change from Baseline SDS at 10 days
measure: psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS)
timeFrame: Change from Baseline SAS at 10 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, DOC
role: STUDY_DIRECTOR
References:
citation: Walters TR, Goldberg DF, Peace JH, Gow JA; Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group. Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials. Ophthalmology. 2014 Jan;121(1):25-33. doi: 10.1016/j.ophtha.2013.07.006. Epub 2013 Sep 8.
citation: Rajpal RK, Ross B, Rajpal SD, Hoang K. Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence. Patient Prefer Adherence. 2014 Jun 25;8:925-31. doi: 10.2147/PPA.S46667. eCollection 2014.
citation: Hoy SM. Bromfenac Ophthalmic Solution 0.07%: A Review of Its Use After Cataract Surgery. Clin Drug Investig. 2015 Aug;35(8):525-9. doi: 10.1007/s40261-015-0309-3.
citation: Donnenfeld ED, Holland EJ, Stewart RH, Gow JA, Grillone LR; Bromfenac Ophthalmic Solution 0.09% (Xibrom) Study Group. Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation. Ophthalmology. 2007 Sep;114(9):1653-62. doi: 10.1016/j.ophtha.2006.12.029. Epub 2007 Apr 19.
citation: Henderson BA, Gayton JL, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution (Bromday) Once Daily Study Group. Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain. Ophthalmology. 2011 Nov;118(11):2120-7. doi: 10.1016/j.ophtha.2011.04.035. Epub 2011 Jul 16.
citation: Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.