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出境医 / 临床实验 / Effect of Bromfenac on Pain Related to Pterygium Surgery

Effect of Bromfenac on Pain Related to Pterygium Surgery

Study Description
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).

Condition or disease Intervention/treatment Phase
Pterygium Pain Drug: 0.1% bromfenac Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery
Actual Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017
Arms and Interventions
Arm Intervention/treatment
Experimental: Artificial tears
0.1% bromfenac VS Artificial tears
 Drug: 0.1% bromfenac
the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.
Other Names:
  • 0.5%Tobramycin dexamethasone
  • 0.3% sodium hyaluronate
Outcome Measures
Primary Outcome Measures :
  1. visual analog scale(VAS) [ Time Frame: 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."

  2. present pain intensity index(PPI) [ Time Frame: 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.


Secondary Outcome Measures :
  1. corneal epithelium healing(CEH) [ Time Frame: Change from Baseline corneal epithelial defect at 10 days ]
    Took the anterior segment photography and slit lamp examination parallel sodium fluorescein staining. The corneal epithelial defect area was stained with fluorescein sodium. Corneal epithelial healing rate is obtained by calculating the difference of the corneal epithelial defect area on day1 from day10, then divided by days.

  2. Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI) [ Time Frame: Change from Baseline TCHI at 10 days ]
    Ocular inflammation was assessed with an automated bulbar redness grading technique, the Oculus Keratograph○R5M (Oculus Optikgerate GmbH, Wetzlar, Germany) by temporal conjunctival hyperaemia index (TCHI). The Oculus Keratograph 5M returns redness using a clinical grading scale of 0.0-4.0 in 0.1 steps.we choose TCHI to evaluate the degree of ocular inflammation, which the grade of 1.2 or less is considered a physiologic degree of bulbar redness.

  3. Symptoms Evaluation by ocular symptom scores(OSS) [ Time Frame: Change from Baseline OSS at 10 days ]
    The irritative symptoms evaluation by ocular symptom scores(OSS),which was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS), which included grading of their symptoms (pain, foreign body sensation, burning sensation, visual fatigue and dryness) using a 4-point scale. The patients determine the quality of irritative symptom by selecting one of the options: None = 0, Perceptible or intermittent fatigue=1, Obvious visual fatigue but tolerable=2, Apparent visual fatigue and hard to bear=3. Higher numbers indicate more severe irritative symptom.

  4. psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS) [ Time Frame: Change from Baseline SDS at 10 days ]
    In the main component of the SDS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. 10 questions are scored forward, the other 10 questions are scored backward. The total score is multiplied by an integer of 1.25 to get the standard score. According to Chinese norms, the cut-off value of SDS standard score is 53, 53-62 is mild, 63-72 is moderate, over 72 is severe, and lower than 53 belongs to the normal.

  5. psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS) [ Time Frame: Change from Baseline SAS at 10 days ]
    In the main component of the SAS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. 10 questions are scored forward, the other 10 questions are scored backward. The total score is multiplied by an integer of 1.25 to get the standard score. According to Chinese norms, the cut-off value of SAS standard score is 53, 53-62 is mild, 63-72 is moderate, over 72 is severe, and lower than 53 belongs to the normal.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
China, Guangdong
Zhongshan Opthalmic Center
Guangzhou, Guangdong, China, 510000
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
Layout table for investigator information
Study Director: Yizhi Liu, DOC Zhongshan Ophthalmic Center, Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • visual analog scale(VAS) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • corneal epithelium healing(CEH) [ Time Frame: Change from Baseline corneal epithelial defect at 10 days ]
    Took the anterior segment photography and slit lamp examination parallel sodium fluorescein staining. The corneal epithelial defect area was stained with fluorescein sodium. Corneal epithelial healing rate is obtained by calculating the difference of the corneal epithelial defect area on day1 from day10, then divided by days.
  • Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI) [ Time Frame: Change from Baseline TCHI at 10 days ]
    Ocular inflammation was assessed with an automated bulbar redness grading technique, the Oculus Keratograph○R5M (Oculus Optikgerate GmbH, Wetzlar, Germany) by temporal conjunctival hyperaemia index (TCHI). The Oculus Keratograph 5M returns redness using a clinical grading scale of 0.0-4.0 in 0.1 steps.we choose TCHI to evaluate the degree of ocular inflammation, which the grade of 1.2 or less is considered a physiologic degree of bulbar redness.
  • Symptoms Evaluation by ocular symptom scores(OSS) [ Time Frame: Change from Baseline OSS at 10 days ]
    The irritative symptoms evaluation by ocular symptom scores(OSS),which was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS), which included grading of their symptoms (pain, foreign body sensation, burning sensation, visual fatigue and dryness) using a 4-point scale. The patients determine the quality of irritative symptom by selecting one of the options: None = 0, Perceptible or intermittent fatigue=1, Obvious visual fatigue but tolerable=2, Apparent visual fatigue and hard to bear=3. Higher numbers indicate more severe irritative symptom.
  • psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS) [ Time Frame: Change from Baseline SDS at 10 days ]
    In the main component of the SDS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. 10 questions are scored forward, the other 10 questions are scored backward. The total score is multiplied by an integer of 1.25 to get the standard score. According to Chinese norms, the cut-off value of SDS standard score is 53, 53-62 is mild, 63-72 is moderate, over 72 is severe, and lower than 53 belongs to the normal.
  • psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS) [ Time Frame: Change from Baseline SAS at 10 days ]
    In the main component of the SAS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. 10 questions are scored forward, the other 10 questions are scored backward. The total score is multiplied by an integer of 1.25 to get the standard score. According to Chinese norms, the cut-off value of SAS standard score is 53, 53-62 is mild, 63-72 is moderate, over 72 is severe, and lower than 53 belongs to the normal.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Bromfenac on Pain Related to Pterygium Surgery
Official Title  ICMJE Bromfenac Ophthalmic Solution 0.1% for Postoperative Ocular Pain and Inflammation Related To Pterygium Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pterygium
  • Pain
Intervention  ICMJE Drug: 0.1% bromfenac
the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.
Other Names:
  • 0.5%Tobramycin dexamethasone
  • 0.3% sodium hyaluronate
Study Arms  ICMJE Experimental: Artificial tears
0.1% bromfenac VS Artificial tears
Intervention: Drug: 0.1% bromfenac
Publications *
  • 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.
  • 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. Review.
  • 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. Review.
  • 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. Epub 2007 Apr 19.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022811
Other Study ID Numbers  ICMJE 2018KYPJ101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Sponsor  ICMJE Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yizhi Liu, DOC Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Zhongshan Ophthalmic Center, Sun Yat-sen University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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