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Table of Contents
ORIGINAL ARTICLE
Year : 2019  |  Volume : 3  |  Issue : 1  |  Page : 1-5

A Prospective study of the effect of bromfenac on tear production


1 Department of Optometry, Faculty of Health Sciences, Abia State University, Uturu, Nigeria
2 Department of Statistics, Faculty of Physical Sciences, Abia State University, Uturu, Nigeria

Date of Submission22-Jun-2019
Date of Acceptance19-Sep-2019
Date of Web Publication13-Dec-2019

Correspondence Address:
Dr. Bright Chiemezie Offorha
Department of Statistics, Faculty of Physical Sciences, Abia State University, Uturu
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/MTSM.MTSM_24_19

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  Abstract 


Context: The effect of bromfenac on tear production of 100 healthy participants aged 16–35 (mean age 23.65 ± 4.38 years) was studied using Schirmer's test. Aim: This study, therefore, is primarily geared toward finding out whether the observed positive effect of bromfenac on the management of dry eye is only as a result of its anti-inflammatory effect on the ocular surface. Settings and Design: The pretest, posttest method of experimental design was used and the posttest was at 30-min interval. The tear production was evaluated before and after the administration of 0.09% of bromfenac. Materials and Methods: Participants were first screened of any systemic or ocular problems. The tear production of the participants' right eye (OD) was measured before the topical administration of bromfenac. A drop of bromfenac was administered, and the tear production of the same OD was measured at 30, 60, and 90 min later and recorded. Statistical Analysis Used: Repeated measures analysis of covariance and t-test methods were used. Results: A decrease in mean tear production from the mean baseline value (19.76 ± 4.61 mm/5 min) was recorded after 30-min interval at 30 min, 60 min, and 90 min, respectively. The lowest mean tear produced was observed at 60 min, this effect was found to be statistically significant (P < 0.001). It was also found that gender significantly influence tear production after the administration of bromfenac. Conclusion: Tear production significantly declines with bromfenac administration almost equally in both genders. Patients prone to dry eyes should therefore use bromfenac cautiously regardless of gender.

Keywords: Bromfenac, nonsteroidal anti-inflammatory drugs, Schirmer's test, tear production


How to cite this article:
Ihesiulor CG, Uka MC, Offorha BC, Nwokike CC, Udo UA, Anonaba CA, Ebere AO. A Prospective study of the effect of bromfenac on tear production. Matrix Sci Med 2019;3:1-5

How to cite this URL:
Ihesiulor CG, Uka MC, Offorha BC, Nwokike CC, Udo UA, Anonaba CA, Ebere AO. A Prospective study of the effect of bromfenac on tear production. Matrix Sci Med [serial online] 2019 [cited 2020 Jul 8];3:1-5. Available from: http://www.matrixscimed.org/text.asp?2019/3/1/1/272989




  Introduction Top


Over the years, nonsteroidal anti-inflammatory drugs (NSAIDs) have been used as safer alternatives to corticosteroids for the treatment of ocular inflammation. They comprise several chemically heterogeneous classes of drugs that possess potent cyclooxygenase inhibitory activity.[1] Topical NSAIDs are classified into six groups based on their chemical composition: indoles, phenylacetic acids, phenyl alkanoic acids, salicyclates, fenamates and pyrazolones, salicyclates, fenamates and salicyclates, fenamates, and pyrazolones are considered too toxic to be used in the eye.[2] The beneficial effects of NSAIDs over corticosteroids include: stabilization of intraocular pressure, provision of analgesia, and reduction in risk of secondary infections.[3] Studies comparing NSAIDs with corticosteroids have demonstrated no significant difference in results between these treatments.[4] However, NSAID treatment appears to be more effective than topical corticosteroids in re-establishing the blood–aqueous barrier.[5] Bromfenac is a NSAID used to treat swelling and pain caused by cataract surgery. The addition of the bromine atom imparts important characteristics to the bromfenac molecule that distinguishes it from other NSAIDs.[6]

Tearing is the secretion of tears, which often serves to clean and lubricate the eyes in response to an irritation to the eyes.[7] In human eyes, the tear film coating the conjunctiva and cornea, known as the precorneal tear film has three essential layers: lipid, aqueous and mucin (from the outermost to the innermost).[8]

Bromfenac has been suggested to be an efficient tool in the management of dry eye. Its contribution to the management of dry eye has been explained to be as a result of its anti-inflammatory effect on the ocular surface.[9] Certainly, the effect of a substance on the rate of tear production can make it an efficient tool in the management of dry eye syndrome in adults. This study, therefore, was carried out to investigate whether the observed positive effect of bromfenac on the management of dry eye is as a result of its anti-inflammatory effect on the ocular surface or that it does have some significant effect on tear production in young adults.

Therefore, the aims of this study is to observe the effect of bromfenac on tear production in young adults. And also, to identify if the effect of bromfenac on tear production occurs similarly or differently in both genders.

Materials and Methods

The participants were first screened of any systemic or ocular problem. The tear production of the participants' right eye (OD) was measured before topical administration of bromfenac. A drop of bromfenac was administered, and the tear production of the same OD was measured 30, 60, and 90 min later and recorded [Appendix 1].



Participants were randomly selected and consent was sought from the subject, and only those who gave their consent were included in this study. Participants <16 years and >35 years were excluded from the study.

Proper health history and external examination were carried out on each of the participants and those whose history and examination were found to yield results that were not suitable for the research such as ocular diseases, those on medications of any sort and so on were not included for this study. Participants with decreased tear production were also excluded from the study.

Statistical analysis

Given that all measurements at different time points were done on the same subject, the observations are not independent; hence, repeated measures analysis of covariance (rANCOVA) was used to account for this correlation between observations in a particular subject. Independent t-test was used to compare tear production between males and females. All statistical tests were carried out at 5% level of significance.


  Results Top


Preliminary investigation

Of 100 participants examined, 47 were males and fifty-three 53 were females. The mean age of participants examined is 23.65 ± 4.36 years (mean ± standard deviation).

From [Figure 1] is evident, there is a mean decrease in tear production at all-time points after bromfenac administration, the lowest was observed at 60 min and the highest at the baseline (0 min) time point.
Figure 1: Boxplot showing five basic statistics of tear production in different time interval, zero indicates the baseline

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In [Figure 2], the mean tear production of males at all-time points is greater than that of the females. The baseline time point recorded the highest tear production for both groups.
Figure 2: Mean tear production between males (m) and females (f) at different time points, zero is the baseline

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[Table 1] shows that among male and female participants, the age group 21–25 years had the highest frequency, 38.30% and 50.94%, respectively. The population of the study had more female participants than male participants with 53% and 47%, respectively.
Table 1: Distribution of subjects according to their age and gender

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[Table 2] shows the mean decrease and percentage decrease of tear production from baseline tear production at all-time intervals. After 30 min of administration, there was 5.73 (29.00%) decrease, after 60 min, there was 7.81 (39.52%) decrease, and after 90 min, there was 5.26 (26.62%) decrease.
Table 2: Mean decrease (percentage) in the tear production (mm) of subjects from baseline at time intervals of 30 min, 60 min, and 90 min after the administration of Bromfenac

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Statistical hypothesis testing

To investigate the effect of bromfenac on tear production the null hypothesis, H0, is topical administration of bromfenac has no significant effect on tear production at different time points. Using rANCOVA method, a P value (F-statistic = 175) <0.001 was obtained, this provides strong evidence against H0. Since there is a significant difference in tear production between any pairs of the time points, it is reasonable we proceed with a post hoc test. Tukey's[10] honestly significance difference test was employed to conduct the post hoc test, to adjust the level of significance for multiple testing, Bonferroni correction was used for the adjustment. It was found that all post-administration time points were significantly different from the baseline pretest administration time point, with a P < 0.001.

Similarly, to investigate if there is a statistically significant effect of gender on tear production, t-test statistics was adopted. Comparison was made between mean tear production of males and females; each subject tear production at different time point was averaged over time. H0: The mean tear production between male and female is the same, with a P = 0.0012 (t-statistic = 3.3317) will fail to accept H0 and conclude that gender influences tear production after bromfenac administration.


  Discussion Top


In this study, we attempted to determine the effect of bromfenac on tear production, 100 participants were included in the study and are within the age range of 16–35 years. The mean age of the participants was 23.35 ± 4.28 years [Table 1].

Furthermore, using the rANCOVA method of analysis, there was a significant effect of topical administration of bromfenac on tear production. The result from this research showed a reduction in the tear production from baseline 19.76 ± 4.61 to 14.03 ± 5.07, 11.95 ± 5.33 and 14.50 ± 4.83, at 30 min, 60 min, and 90 min, respectively, after administration of bromfenac [Table 2]. Bromfenac is a nonsteroidal and inflammatory drug that possesses analgesic, anti-pyretic and anti-inflammatory characteristics and is known to be used for the treatment of pain and swelling following cataract surgery.[11] This result is in accordance to a research carried out by Crandall and Leopard,[12] which showed that several classes of drugs decrease aqueous tear secretion including drugs with analgesic effects of which bromfenac falls into.

The mean baseline tear production was 19.76 mm, and the mean decrease of tear production was 5.73 mm (29.00%), 7.81 mm (39.52%), and 5.26 mm (26.62%) after 30 min, 60 min, and 90 min, respectively [Table 2]. The highest mean decrease in tear production was observed at 60 min.

The mean distribution of tear production in both genders at the different time intervals after the administration of bromfenac [Figure 2] showed that the male participants had higher baseline values and higher tear production values at the different time intervals compared to the female participants.{Figure 2}

The setting of this limits the generalization of its findings to the general populace since only young adult within the institution were considered, further study could consider a wider age range and also participants outside the institution for better representation. Sample size could also be increased for more accuracy and increased power.


  Conclusions Top


In summary, this study has shown that bromfenac significantly affect tear production among young adults. Similarly, gender seems to influence tear production after the application of bromfenac. Hence, Patients prone to dry eyes should, therefore, use bromfenac cautiously.



Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: Focus on bromfenac ophthalmic solution. Clin. Ophthalmol. 2009;3:199-210.  Back to cited text no. 1
    
2.
Flach AJ. Topical nonsteroidal anti-inflammatory drugs in ophthalmology. Int. Ophthalmol. Clin. 2002;42:1-1.  Back to cited text no. 2
    
3.
Hashimoto T, Igarashi A, Hoshina F, Yamada M, Toyoda Y, Notsu Y, et al. Effects of nonsteroidal anti-inflammatory drugs on experimental allergic conjunctivitis in guinea pigs. J. Ocul. Pharmacol. Ther. 2003;19:569-77.  Back to cited text no. 3
    
4.
El-Harazi SM, Ruiz RS, Feldman RM, Villanueva G, Chuang AZ. A randomized double-masked trial comparing ketorolac tromethamine 0.5%, diclofenac sodium 0.1%, and prednisolone acetate 1% in reducing post-phacoemulsification flare and cells. Ophthalmic Surg. Lasers. 1998;29:539-44.  Back to cited text no. 4
    
5.
Roberts CW, Brennan KM. A comparison of topical diclofenac with prednisolone for postcataract inflammation. Arch. Ophthalmol. 1995;113:725-7.  Back to cited text no. 5
    
6.
Walsh DA, Moran HW, Shamblee DA, Uwaydah IM, Welstead WJ Jr., Sancilio LF, et al. Antiinflammatory agents 3. Synthesis and pharmacological evaluation of 2-amino-3-benzoylphenylacetic acid and analogues. J. Med. Chem. 1984;27:1379-88.  Back to cited text no. 6
    
7.
Farandos NM, Yetisen AK, Monteiro MJ, Lowe CR, Yun SH. Contact lens sensors in ocular diagnostics. Adv. Healthc. Mater. 2015;4:792-810.   Back to cited text no. 7
    
8.
Moshirfar M, Pierson K, Hanamaikai K, Santiago-Caban L, Muthappan V, Passi SF, et al. Artificial tears potpourri: A literature review. Clin. Ophthalmol. 2014;8:1419-33.  Back to cited text no. 8
    
9.
Fujishima H, Fuseya M, Ogata M, Murat D. Efficacy of bromfenac sodium ophthalmic solution for treatment of dry eye disease. Asia Pac. J. Ophthalmol.(Phila.). 2015;4:9-13.  Back to cited text no. 9
    
10.
Tukey JW. Comparing individual means in the analysis of variance. Biometrics. 1949;5:99-114.  Back to cited text no. 10
    
11.
Haberfeld H. Austria-Codex (in German). Vienna: Osterreichischer Apothekerverlag; 2015.  Back to cited text no. 11
    
12.
Crandall DC, Leopard H. The influence of systemic drugs in tear constituents. J. Opthalmol. 1999; 86:115-25.  Back to cited text no. 12
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]



 

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