Effect of Bromfenac on Pain Related to Pterygium Surgery

NCT04022811 | Completed Phase 4

• 1 other identifier: 2018KYPJ101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Pterygium; Pain

Keywords

Pterygium; Bromofenac; Pain

Outcome Measures

Primary Outcomes (2)

• visual analog scale(VAS)

  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."

  Change from Baseline VAS at 10 days

• present pain intensity index(PPI)

  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.

  Change from Baseline PPI at 10 days

Secondary Outcomes (5)

• corneal epithelium healing(CEH)

  Change from Baseline corneal epithelial defect at 10 days

• Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI)

  Change from Baseline TCHI at 10 days

• Symptoms Evaluation by ocular symptom scores(OSS)

  Change from Baseline OSS at 10 days

• psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS)

  Change from Baseline SDS at 10 days

• psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS)

  Change from Baseline SAS at 10 days

Study Arms (1)

Artificial tears

EXPERIMENTAL

0.1% bromfenac VS Artificial tears

Drug: 0.1% bromfenac

Interventions

0.1% bromfenac DRUG

the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.

Also known as: 0.5%Tobramycin dexamethasone, 0.3% sodium hyaluronate

Artificial tears

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient factors: lack of cooperation and poor compliance.
• Severe dry eye, Sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface.
• Glaucoma or high intraocular pressure (above 21 mmHg), active uveitis, retinal detachment and other diseases.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (2)

Zhongshan Opthalmic Center

Guangzhou, Guangdong, 510000, China

Location

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (6)

• 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.

  PMID: 24021896 BACKGROUND

• 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.

  PMID: 25028541 BACKGROUND

• 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.

  PMID: 26177719 BACKGROUND

• 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.

  PMID: 17445902 BACKGROUND

• 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.

  PMID: 21762992 BACKGROUND

• 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.

  PMID: 21751945 BACKGROUND

MeSH Terms

Conditions

Pterygium; Pain

Interventions

bromfenac; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yizhi Liu, DOC

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 17, 2019
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)