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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 2  |  Page : 55-58

Comparing the efficacy of 2% topical rebamipide and 0.1% topical sodium hyaluronate with or without 0.05% topical cyclosporine in patients with dry eye disease


KJ Somaiya Medical College and Research Centre, Mumbai, Maharashtra, India

Date of Submission16-Jul-2019
Date of Decision25-Jun-2020
Date of Acceptance22-Apr-2021
Date of Web Publication31-Jul-2021

Correspondence Address:
Priyanka V Gandhi
C 420, Suhyog Apt. Vazira Naka Borivali, West Mumbai - 400 091, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcor.jcor_50_19

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  Abstract 


Background: Dry Eye Disease (DED) is a multifactorial and complex disease of the ocular surface, with a high prevalence in adults. Aims and Objectives: To compare the efficacy of 2% topical Rebamipide and 0.1% topical Sodium hyaluronate with or without 0.05% topical cyclosporine in patients with dry eye disease (DED). Materials and Methods: This prospective, randomised, comparative, interventional study was conducted at a tertiary level academic centre on 240 eyes of 120 patients having DED, with Schirmer's test (without anesthesia) value less than or equal to 10mm and tear film breakup time (TBUT) less than or equal to 10 secs. After detailed ophthalmic examination, patients were randomly allocated in 4 different groups (A B C D). Group A were given 2% topical Rebamipide, group B received 2% topical Rebamipide with 0.05% topical Cyclosporine, group C were started on 0.1% topical Sodium Hyaluronate and group D were given 0.1% topical Sodium Hyaluronate with 0.05% cyclosporine. Each of these drops was given for 4 times a day for a period of 12 weeks. All patients were followed up after 2 weeks, 4 weeks and 12 weeks. Results: Out of 120 patients, 79 (65.83%) were female and 41 (34.16%) were male. The change in the mean schirmer's score and mean TBUT score was statistically significant in all four groups from baseline to 12 weeks (p<0.05). On comparing with each other, no significance difference was noted in any group. Conclusion: According to our study, 3 months of treatment with either 2% topical Rebamipide or 0.1% sodium hyaluronate is equally effective for DED and addition of 0.05% cyclosporine have no adjunctive role.

Keywords: Conjunctival impression cytology, cyclosporine, rebamipide, sodium hyaluronate


How to cite this article:
Gandhi PV, Telang O, Morepatil V. Comparing the efficacy of 2% topical rebamipide and 0.1% topical sodium hyaluronate with or without 0.05% topical cyclosporine in patients with dry eye disease. J Clin Ophthalmol Res 2021;9:55-8

How to cite this URL:
Gandhi PV, Telang O, Morepatil V. Comparing the efficacy of 2% topical rebamipide and 0.1% topical sodium hyaluronate with or without 0.05% topical cyclosporine in patients with dry eye disease. J Clin Ophthalmol Res [serial online] 2021 [cited 2022 Jul 2];9:55-8. Available from: https://www.jcor.in/text.asp?2021/9/2/55/322793



Dry eye disease (DED) is one of the most frequently encountered ocular morbidities. Twenty-five percent of the patients who visit ophthalmic clinic report symptoms of DED, making it a growing public health problem and one of the most common conditions seen by eye care practitioners.[1]

The burden of DED to the patient is not trivial. Studies suggest that DED can have a considerable impact on visual function, daily activities, social and physical functioning, and quality of life.[2]

The diagnosis of DED is generally made by combining information obtained from the physical examination and performing diagnostic tests. Poor correlation between clinical signs and patient symptoms would require the use of multiple tests. In general, two or more tests are performed to permit an absolute diagnosis of DED. Symptom questionnaires can also be used to help establish a diagnosis of DED and to assess the effects of treatments or to grade disease severity.[3]

The current treatment is based on the use of topically applied artificial tears, tear retention management, stimulation of tear secretion, and the use of anti-inflammatory drugs.[4] Artificial tear substitutes are considered mainstay in the treatment of DED. However, they do not contain the antibodies, vitamins, and nutrients found in normal tears that are essential for eye health. In addition to this, preservatives used in artificial tear drops may damage the delicate cells on the surface of the eyes or cause inflammation. They require frequent instillation and provide only symptomatic relief.

Thus, a study was required to evaluate other better and adjuvant treatment options for effective management of DED. Hence, the aim of our study was to compare the efficacy of 2% rebamipide and 0.1% sodium hyaluronate with or without 0.05% cyclosporine in the treatment of DED.


  Materials and Methods Top


This was a prospective, randomized, comparative, and interventional study that included 120 patients with DED, attending the hospital's outpatient department from July 2016 to August 2018. Our study adhered to the tenets of the Declaration of Helsinki and was approved by the institutional review board. Written informed consent was obtained from all enrolled patients. All consenting patients >18 years of age having one or all of the dry eye-related ocular symptoms such as foreign body sensation, blurring of vision, photophobia, ocular discomfort, and burning sensation with Schirmer's test value ≤10 mm and Tear Film Break-up Time (TBUT) value ≤10 s were included in the study. Those with any other anterior segment disease, or on any ocular medication or having undergone ocular surgery within 3 months were excluded from the study. All patients underwent a complete ophthalmic examination, Schirmer's test, TBUT following which enrolled patients were subjected to conjunctival impression cytology (CIC). The CIC slides were evaluated by a single pathologist who was masked to the origin of the slides. The slides were observed under 40x magnification and were graded according to Nelson criteria [Annexure 1]. All individuals were asked to fill a questionnaire (Salisbury) regarding the severity of their symptoms.

All the participants were divided with computer-generated random numbers into four groups (ABCD). Group A was given 2% topical rebamipide, whereas Group B was started on 2% topical rebamipide with 0.05% topical cyclosporine. Group C received 0.1% topical sodium hyaluronate, whereas Group D was given 0.1% sodium hyaluronate with 0.05% cyclosporine. Each of these drops was given four times a day for 3 months.

All patients were followed up after 2 weeks, 4 weeks, and 3 months from baseline. Patients were subjected to complete anterior segment evaluation with Schirmer's test, TBUT, CIC and subjective questionnaire (Annexure 2) at each follow up.

The data were analyzed using SPSS software 24 trial version. Frequency percentage, mean, and standard deviation were used to summarize the data. Repeated measure ANOVA, one-way ANOVA, paired t-test, and Chi-square test was used to test the level of significance (P < 0.05).


  Results Top


A total of 120 patients suffering from DED were enrolled in our study, with thirty patients in each of the four groups. Out of total, 65% were female and 35% were male.

The mean Schirmer's score by repeated measure ANOVA test showed that it differed significantly from baseline to 3 months in all the groups. However, no significant difference was noted when groups were compared with each other [Table 1].
Table 1: Comparison of mean Schirmer's score, mean tear breakup time, and mean subjective scoring between all the groups

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The mean TBUT values showed significant improvement in all groups from baseline to 3 months while no statistical difference when compared to each other [Table 1].

Logistic regression analysis on conjunctival cytological study showed significant improvement to Grade II and Grade I at the end of 3 months in >40% of the total number of eyes [Table 2] and [Figure 1], [Figure 2], [Figure 3], [Figure 4].
Table 2: Comparison of the grades of conjunctival impression cytology between the study groups (number of eyes)

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Figure 1: Photomicrograph of conjunctival impression cytology in patients using 0.1% sodium hyaluronate at (a) baseline, (b) 2 weeks, (c) 4 weeks, (d) 3 months

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Figure 2: Photomicrograph of conjunctival impression cytology of patients using 2% rebamipide and 0.05% cyclosporine at (a) baseline, (b) 2 weeks, (c) 4 weeks, (d) 3 months

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Figure 3: Photomicrograph of conjunctival impression cytology in the patient using 2% rebamipide at (a) baseline, (b) 2 weeks, (c) 4 weeks, (d) 3 months

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Figure 4: Photomicrograph of conjunctival impression cytology in patients using 0.1% sodium hyaluronate and 0.05% cyclosporine at (a) baseline, (b) 2 weeks, (c) 4 weeks, (d) 3 months

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By the end of 3 months, all the groups experienced a statistically significant improvement in their symptoms. However, the comparison between each group was insignificant [Table 1].


  Discussion Top


In 2017, Tear Film and Ocular Surface Society (TFOS), Dry Eye Workshop (DEWS) II refined the global dry eye definition as, Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.”[5]

Hyperosmolarity at the ocular surface initiates an inflammatory sequence leading to damage of epithelial cells, goblet cells, and the glycocalyx observed clinically as punctate epitheliopathy and tear film instability and breakup. Described by the TFOS DEWS II as a “vicious circle” of inflammation, this process is the common final pathway for all forms of DED. In a self-perpetuating cycle, evaporative losses cause frictional damage to the lid and ocular surface, exacerbating hyperosmolarity, and inducing the inflammatory sequence yet again. The loss of homeostasis of the ocular surface is the key pathophysiologic change that defines DED.[6]

In our study, both 2% rebamipide (Group A) and 0.1% sodium hyaluronate (Group C) demonstrated statistically significant efficacy improvements for the treatment of dry eye. The 3 months, four times daily ocular instillation of these drops were effective at improving both the objective signs and the subjective symptoms of dry eye. On comparing both Group A and Group C, no significant difference was observed. Thus, both 2% rebamipide and 0.1% sodium hyaluronate are equally effective for the treatment of DED.

Few studies in the literature on 2% rebamipide[7],[8] and 0.1% sodium hyaluronate[9],[10] correlate with our findings.

At the end of 3 months, both Group B and Group D had significant improvement, however, on comparing with Group A and Group D, respectively, it was observed that 0.05% topical cyclosporine have no adjuvant role in the treatment of DED.

While existing literature has studies done for each of these drugs but our study took this analysis a step further and compared these drugs with each other to aid in better management of DED.

One of the limitations of our study was lack of reference as no similar study has been done till now. In addition, small sample size and absence of well-defined gold standard investigation further restricted the outcome of our study.


  Conclusion Top


According to the results of the present study, the use of either 2% topical rebamipide or 0.1% topical sodium hyaluronate is equally effective in the treatment of DED, and addition of 0.05% topical cyclosporine has no adjunctive role.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Annexures







 
  References Top

1.
O'Brien PD, Collum LM. Dry eye: Diagnosis and current treatment strategies. Curr Allergy Asthma Rep 2004;4:314-9.  Back to cited text no. 1
    
2.
Miljanović B, Dana R, Sullivan DA, Schaumberg DA. Impact of dry eye syndrome on vision-related quality of life. Am J Ophthalmol 2007;143:409-15.  Back to cited text no. 2
    
3.
Phadatare SP, Momin M, Nighojkar P, Askarkar S, Singh KK. A comprehensive review on dry eye disease: Diagnosis, medical management, recent developments, and future challenges. Adv Pharm 2015;2015:12.  Back to cited text no. 3
    
4.
Lin H, Yiu SC. Dry eye disease: A review of diagnostic approaches and treatments. Saudi J Ophthalmol 2014;28:173-81.  Back to cited text no. 4
    
5.
Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, et al. Corrigendum to “TFOS DEWS II pathophysiology report.” Ocul Surf 2017;15:438-510.  Back to cited text no. 5
    
6.
Lemp MA. Advances in understanding and managing dry eye disease. Am J Ophthalmol 2008;146:350-6.  Back to cited text no. 6
    
7.
Kinoshita S, Oshide n K, Awamura S, Suzuki H, Nakamichi N, Yokoi N, et al. A randomized, multicenter phase 3 study comparing 2% rebamipide (OPC-12759) with 0.1% sodium hyaluronate in the treatment of dry eye. Ophthalmology 2013;120:1158-65.  Back to cited text no. 7
    
8.
Dhawan M, Tania Hans, Baltej Singh. Rebamipide 2% ophthalmic suspension for the treatment of allergic keratoconjunctivitis: A hospital based study. Delhi J Ophthalmol 2016;26:246-9.  Back to cited text no. 8
    
9.
Park Y, Song JS, Choi CY, Yoon KC, Lee HK, Kim HS. A randomized multicenter study comparing 0.1%, 0.15%, and 0.3% sodium hyaluronate with 0.05% cyclosporine in the treatment of dry eye. J Ocul Pharmacol Ther 2017;33:66-72.  Back to cited text no. 9
    
10.
Perry HD, Donnenfeld ED. Topical 0.05% cyclosporin in the treatment of dry eye. Expert Opin Pharmacother 2004;5:2099-107.  Back to cited text no. 10
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2]



 

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