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Year : 1985  |  Volume : 33  |  Issue : 5  |  Page : 285-288

Topical sodium cromoglycate in management of chronic non-infectious conjunctivitis: A Double blind controlled clinical trial

Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India

Correspondence Address:
R B Vajpayee
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi-110029
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Source of Support: None, Conflict of Interest: None

PMID: 3939626

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How to cite this article:
Vajpayee R B, Gupta S K, Angra S K. Topical sodium cromoglycate in management of chronic non-infectious conjunctivitis: A Double blind controlled clinical trial. Indian J Ophthalmol 1985;33:285-8

How to cite this URL:
Vajpayee R B, Gupta S K, Angra S K. Topical sodium cromoglycate in management of chronic non-infectious conjunctivitis: A Double blind controlled clinical trial. Indian J Ophthalmol [serial online] 1985 [cited 2021 Jan 25];33:285-8. Available from: https://www.ijo.in/text.asp?1985/33/5/285/30732

Table 2

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Table 2

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Table 1

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Table 1

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Non-infectious chronic conjunctivitis is often caused by an irritative component. There are many factors that may be respon­sible such as foreign bodies, atmospheric contaminants, ingrowing eye lashes or even prolonged use of eye drops. There is no specific treatment for chronic non-infectious conjunctivitis. Decongestents, antihistminics and steriods are commonly used in this condi­tion. Amongst these, steriods are most useful but prone to side effects. Sodium cromoglycate has been shown to be safe and effective in the treatment of seasonal con­junctivitis[1],[2] and vernal catarrh[3],[4]. However, only limited work has been done to evaluate the role, of topical sodium cromoglycate in chronic non-infectious conjunctivitis[5]. In the present study we planned to evaluate the efficacy of topical 2% sodium cromoglycate in patients of chronic non-infectious con­junctivitis which is difficult to manage and often causes continuous discomfort.

  Material and methods Top

Fifty-four patients of bilateral chronic non-infectious conjunctivitis were selected randomly after ruling out any possible infective aetiology. On the initial visit ocular symptoms, their nature and periodi­city was noted. Symptoms and signs were evaluated on 4 points scale; (0 =none, I = mild, 2=moderate and 3= severe) Criteria for exclusion were, failure of patient to turn up for the follow up, involvement of epis­cleral vessels, vernal catarrh, pregnancy, concurrent topical medication and allergy to sodium cromoglycate or its vehicle. A wash­out period of one week was given if a patient was using some topical or systemic medica­tion.

Each patient was given 2% sodium cromoglycate drops in one eye and vehicle in the contralateral eye QID for 4 weeks on a random basis. The drops were coded and the code was broken at the completion of trial. The evaluation was based on the patient's subjective report of improvement in ocular symptoms and changes observed by slit lamp biomicroscopy. For the purpose of analysis, average mean score of each of the studied parameter was calculated. The average mean score of the placebo and sodium cromoglycate treated eyes at each examination was compared with the average mean score of each at the time of presenta­tion. Percentage improvement was com­pounded from the average mean score of each parameter as compared to its base line average mean score.

  Observations Top

Of the 54 patients studied 37 were males and 17 females with age ranging from 9 to 60 years. These patients had suffered from chronic conjunctivitis between 1 month to 6 years. The incidence and over all severity of the symptoms and signs varied with all the patients having hyperaemia and most of them also complaining itching, watering, burning and foreign body sensation.

The comparison of subjective score record after subsequent visit indicated that after a 4 weeks trial, 2% sodium cromoglycate drops were ineffective in the management of chronic non-infectious conjunctivitis [Table - 1]. There was no statistically signi­ficant difference between placebo and sodium cromoglycate groups in relieving symptoms like itching, watering and burning [Table - 2]. The hyperaemia was unaffected in both the treatment groups. Five patients withdrew during the trial period.

  Discussion Top

54 patients (108 eyes) of chronic non­infectious conjunctivitis were subjected to a 4 weeks trial to evaluate the efficacy of topical sodium cromoglycate. The results of this trial clearly demonstrate that sodium cromoglycate drops are no more effective than placebo in the management of chronic non­infectious conjunctivitis.

Allergic reactions are a common cause of chronic non-infectious conjunctivitis and repeated exposures to relatively diluted allergens in susceptible patients, can result in chronic inflammatory reaction. Elimination of the offending allergen is the ideal way of treatment, however, this is not always possi­ble particularly when more than one allergen is involved. Desensitization is not usually very effective in preventing symptoms of chronic non-infectious conjunctivitis and palliative measures such as vasoconstrictors and antihistaminics have limited use. Topical steroids are effective but they are prone to cause serious complications. A safe alter­native, disodium cromoglycate exhibits its pharmacological activity by stabilizing mast cell membrane, thereby preventing degranu­lation. However, although, disodium cromoglycate markedly reduces degranula­tion of mast cells in certain tissue but in others no such activity is demonstrated[6]. Differences in membrane structure on com­position of these cells may account for this reduced drug-cell interaction and this may hold true in case of mast cells of human conjunctiva. In fact mast cells from different species or even from individual tissues within a single animal have been shown to vary significantly in their response to histamine release[6].

In our series of cases, failure of disodium cromoglycate may be attributed to decreased drug-cell interaction of conjunctival mast cells. Similar to our results other studies also have shown no beneficial response to disodium cromoglycate in ocular atopy[7],[8],[9]. It would be intresting to study the degree of drug cell interaction of conjunctival mast cells with disodium cromoglycate in-vitro experiments and till then role of disodium cromoglycate will remain controversial in ocular atopy.

  Summary Top

A double blind, randomized, noncrosso­ver 4 weeks trial was conducted in 54 patients (1(8 eyes) of chronic non-infectious conjunctivitis to evaluate the efficacy of 2% sodium cromoglycate vis-a-vis placebo. It was concluded that topical 2% sodium cromoglycate is ineffective in the management of chronic non-infectious conjunctivitis. No side effects were reported during the trial

  References Top

Bijsterveld Van, O.P. 1984 Acta Ophthalmol, 62 : 479-484.  Back to cited text no. 1
Easty D. Rice NSC, Jones B.R.; 1971, Trans, Ophthalmol Soc. UK. 91 : 491  Back to cited text no. 2
Rice N.S.C.. Easty D, Garner A et al, 1971, Trans. Ophthalmol Soc U.K. 91 : 483  Back to cited text no. 3
Easty D., Rice, N.S,C. Jones BR.. 1972, Clin. Allergy 2 : 99  Back to cited text no. 4
Leino M. Tuobinen E,, 1980. Acta Ophthalmol 18 :121-124  Back to cited text no. 5
Pearce, F.L. : Klin, Wochenschr. 60:954-957. 1982  Back to cited text no. 6
Hyams, S.W., Bralik M, Neumann, E J , 1975, Paediat. Ophthalmol. 12: 1168.  Back to cited text no. 7
Bansal S.L., Dhir SP, Jain I.S., 1981, Ind. J, Ophthalmol, 28 : 4  Back to cited text no. 8
Vajpayee R, Kumar S. Sharma M, 1985, Ind, J. Ophthalmol. 33: 151.  Back to cited text no. 9


  [Table - 1], [Table - 2]


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