|Year : 1985 | Volume
| Issue : 5 | Page : 285-288
Topical sodium cromoglycate in management of chronic non-infectious conjunctivitis: A Double blind controlled clinical trial
RB Vajpayee, SK Gupta, SK Angra
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India
R B Vajpayee
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi-110029
Source of Support: None, Conflict of Interest: None
|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 2020 Apr 10];33:285-8. Available from: http://www.ijo.in/text.asp?1985/33/5/285/30732
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, and vernal catarrh,. However, only limited work has been done to evaluate the role, of topical sodium cromoglycate in chronic non-infectious conjunctivitis. 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|| |
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|| |
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|| |
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. 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.
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,,. 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|| |
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
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[Table - 1], [Table - 2]