A Phase 4 interventional study of 0.1% bromfenac in Pterygium and Pain, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Completed at 2 sites in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Phase 4, Interventional, and Treatment
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).
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Exclusion Criteria
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.
Also known as: 0.5%Tobramycin dexamethasone, 0.3% sodium hyaluronate
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."
Time frame: 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.
Time frame: Change from Baseline PPI at 10 days
corneal epithelium healing(CEH)
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.
Time frame: Change from Baseline corneal epithelial defect at 10 days
Inflammation Evaluation by temporal conjunctival hyperaemia index (TCHI)
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.
Time frame: Change from Baseline TCHI at 10 days
Symptoms Evaluation by ocular symptom scores(OSS)
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.
Time frame: Change from Baseline OSS at 10 days
psychological state changes of depression was evaluated with Self-rating Depression Scale(SDS)
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.
Time frame: Change from Baseline SDS at 10 days
psychological state changes of anxiety was evaluated with Self-rating Anxiety Scale(SAS)
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.
Time frame: Change from Baseline SAS at 10 days
Plan to share: No
Ran from Oct 2016 to primary completion in Oct 2017, 12 months.
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Studies of the drug tested here: Bromfenac
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