Year : 1987 | Volume
: 35 | Issue : 4 | Page : 190--193
Evaluation of oxymetazoline and naphazoline in benign red eyes : A double blind comparative clinical trial
BK Nayak, Kamal Kishore, SK Gupta
B K Nayak
The efficacy of topical oxymetazoline and naphazoline has been evaluated in 20 patients suffering from benign red eyes The results of the present study reveal that ocular decongestant action of 0.01 % oxymetazoline on 3rd and 7th day was 66.66% and 80.55% as compared to 22.22% and 50% of 0.01% naphazoline respectively Significant improvement in the conjunctival symptoms viz itching, foreign body sensation, watering and burning sensation, was achieved with oxymetazoline as compared to naphazoline. No ocular toxicity was observed with oxymetazoline during the study period The findings of this study suggest that 0.01% oxymetazoline is a superior alternative to presently available decongestants.
|How to cite this article:|
Nayak B K, Kishore K, Gupta S K. Evaluation of oxymetazoline and naphazoline in benign red eyes : A double blind comparative clinical trial.Indian J Ophthalmol 1987;35:190-193
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Nayak B K, Kishore K, Gupta S K. Evaluation of oxymetazoline and naphazoline in benign red eyes : A double blind comparative clinical trial. Indian J Ophthalmol [serial online] 1987 [cited 2021 Jan 27 ];35:190-193
Available from: https://www.ijo.in/text.asp?1987/35/4/190/26187
Allergic conjunctivitis and non- infectious conjunctivitis are two common causes of benign red eye  . It is basically a conjunctival reaction to airborne allergens in hypersensitive individuals who often have history of allergy (asthma, eczema, rhinitis etc). The common symptoms are itching, watering, redness, burning sensation and chemosis with no clinical signs of conjunctival papillae or follicles  . Local instillation of decongestant drops is one mode of treatment for such conditions Although corticosteroids are effective in benign red eyes, glaucoma and cataract are two well known serious side effects of prolonged topical use , . Therefore, there is need for decongestants with good efficacy, with longer duration of action and minimum side effects.
A double blind placebo controlled clinical study  has shown that 0.01 % of oxymetazoline drops are highly effective in such conditions Hence the aim of the present study was to compare the ocular decongestant effect of 0.01% oxymetazoline drops with the most widely used ocular decongestant agent 0.01% naphazoline drops in a double blind study.
Material and methods
A total number of 20 patients with the diagnosis of non-specific allergic conjunctivitis were taken from the outdoor patient department of Rajendra Prasad Centre, AIIMS. for the present study. Infective aetiology was ruled out clinically and in 3 doubtful cases the bacterial culture of the conjunctival discharge was performed.
The detailed ocular examination was done. The best corrected distant and near visual acuity anterior segment findings, fundus examination, near point of accommodation and intraocular pressure were recorded in all the patients at each visit Conjunctival signs and symptoms (itching, burning, foreign body sensation, watering and hyperaemia) were estimated on a 4 point scale 0 = none I = mild 2 = moderate 3= severe.
Patients with vernal catarrh, pregnancy, allergy to oxymetazoline and infectious conjunctivitis were excluded from the study. All the 20 randomly selected cases were divided into two equal groups of 10 each. One group received 0.01% of oxy metazoline while the other 0.01 % drops of naphazoline which were coded and the code was broken at the end of the study. The patients were instructed to instil the given drug into each eye four times a day. The patients were examined before and after the instillation of drops at30 min 4 hrs, 6 hrs, 3rd day, and 7th day. The total period of study was 7 days. All the patients were advised not to take any other medication during the trial period of 7 days.
For the purpose of analysis average mean score of each of the studied parameters was calculated. The average mean score of the oxymetazoline and naphazoline 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 baseline average mean score P values were calculated for each conjunctival sign and symptoms at all examined time intervals between the two groups and of each sign and symptom within the same group at different time intervals.
[Table 1] depicts the mean average score with standard deviations of each parameter studied for oxymetazoline and naphazoline groups on each follow up. Percentage improvement of the studied parameters at each follow up in oxymetazoline and naphazoline groups is represented in [Table 2]. On statistical analysis of each conjunctival sign and symptom examined at different time intervals between the two groups no statistical significance was observed for itching, foreign body sensation, burning and watering. However, in the case of hyperaemia there was definite significance noted at 30 min. (p <0.01), 4 hrs (p <0.05),3 days (p <0.01) intervals.
The details of statistical analysis of the various signs and symptoms at 3 days and 7 days intervals within the same group are shown in [Table 3].
No side effects were observed during the entire study. Intraocular pressure, near point of accommodation, distant and near visual acuity remained unaffected in all the patients studied. No change in the anterior segment or fundus could be detected in any patient The bacterial culture of the conjunctival swab of the three patients was negative.
The various conjunctival signs and symptoms evaluated in this study at different time intervals clearly show that the improvement with oxymetazoline is more than that obtained with naphazoline [Table 1],[Table 2] and [Table 3]. The percentage improvement of the studied parameters was much more with oxymatazoline when compared to naphazoline [Table 2]. The decongestant effect (control of hyperaemia) was 66.66% with oxymetazoline and 22.22% with naphazoline on the 3rd day. However, the percentage improvement was 80.55% and 50.0% respectively on 7th day. This decrease in the difference of decongestant effect between the two drugs on 7th day indicates that oxymetazoline is quick acting apart from being more efficacious. The level of statistical significance was more with oxymetazoline (p <0.001) as compared to naphazoline) (p <0.05) on 3rd day.
The improvement in the conjunctival symptoms of benign red eyes (itching, foreign body sensation, burning and watering) was statistically significant in patients treated with oxymetazoline on the 7th day whereas it was not-significant in the case of naphazoline. This could be due to superior decongestant and antihistaminic effect of oxymetazoline thus justifying the superior therapeutic response obtained with oxymetazoline in patients with benign red eyes.
Naphazoline is one of the most widely used decongestant but sedation has been reported with its use. In our study none of the patients complained of any side effect with either of the two drugs
|1||Cowen, D.E 1966: Ear Nose Throat: 45, 5861.|
|2||Stephen, J K Miller : 1984: In Parsons diseases of the Eye P. 120, Churchill Livingstone.Frandsen, E: 1964: Acta Ophthalmol 42,108-112.|
|3||Goldmann, H : 1962: Arch Ophthalmol 68, 621-630.|
|4||Vajpayee, R BR Gupta, S K Angra, S. K Uppal R,R K, Sharma, Y R : 1986: Ind. J. Ophthalmol 34: 33-36.|
|5||Gupta, S. K, Uppal, RK, Vajpayee, RB.: 1985 lnt Symp. Ocular Pharm New Delhi-40-45.|