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PterygiumPhase 4NCT04022811

Effect of Bromfenac on Pain Related to Pterygium Surgery

A Phase 4 study testing 0.1% bromfenac in people with Pterygium and Pain, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Pterygium, Pain
What is being tested?
0.1% bromfenac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
Oct 2016to Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhongshan Opthalmic Center

    Guangzhou, Guangdong, 510000

  • Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

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).

Read the 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.

Conditions
Pterygium, Pain
Being tested
0.1% bromfenac
Keywords
Pterygium, Bromofenac, Pain
Medical subject headings
Pterygium, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.1% bromfenacDrug

    Also called 0.5%Tobramycin dexamethasone, 0.3% sodium hyaluronate

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

Study groups in NCT04022811
Study groupRoleWhat they receive
Artificial tearsExperimental0.1% bromfenac VS Artificial tears
Receives: Drug: 0.1% bromfenac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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."

    Measured: Change from Baseline VAS at 10 days

  2. 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.

    Measured: Change from Baseline PPI at 10 days

Secondary outcomes (5)

  1. 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.

    Measured: Change from Baseline corneal epithelial defect at 10 days

  2. 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.

    Measured: Change from Baseline TCHI at 10 days

  3. 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.

    Measured: Change from Baseline OSS at 10 days

  4. 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.

    Measured: Change from Baseline SDS at 10 days

  5. 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.

    Measured: Change from Baseline SAS at 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2019
  2. Study startOct 2016
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04022811
Sponsor's protocol ID
2018KYPJ101
Status last verified
Jul 2019
First submitted
22 May 2018
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24021896

  • 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.

    PubMed 25028541

  • 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.

    PubMed 26177719

  • 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.

    PubMed 17445902

  • 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.

    PubMed 21762992

  • 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.

    PubMed 21751945

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.1% bromfenac in people with Pterygium and Pain, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visual analog scale(VAS) (time frame: Change from Baseline VAS at 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04022811, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.

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