|Year : 1986 | Volume
| Issue : 1 | Page : 33-36
Management of benign red eye (evaluation of topical oxymetazoline-a double masked study)
RB Vajpayee, SK Gupta, SK Angra, RK Uppal, YR Sharma, MR Mehta
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I I.M.S. New Delhi, India
R B Vajpayee
Dr. R.P. Centre for Ophthalmic Sciences 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, Uppal R K, Sharma Y R, Mehta M R. Management of benign red eye (evaluation of topical oxymetazoline-a double masked study). Indian J Ophthalmol 1986;34:33-6
|How to cite this URL:|
Vajpayee R B, Gupta S K, Angra S K, Uppal R K, Sharma Y R, Mehta M R. Management of benign red eye (evaluation of topical oxymetazoline-a double masked study). Indian J Ophthalmol [serial online] 1986 [cited 2020 Jul 15];34:33-6. Available from: http://www.ijo.in/text.asp?1986/34/1/33/26347
The clinician is often faced with the problem of conjunctival vasodilatation of an undetermined nature after all afforts to arrive at a pathologic diagonosis have been exhausted. Allergic conjunctivities and non-infectious conjunctivities are the two common causes for these red eyes. Once the physician is certain about the benign nature of red eye, vasoconstrictors become an option.
Oxymetazoline, and imidazoline are sympathomimetic vasoconstrictor, has been used topically for nasal decongestant effect for a number of years. Studies have indicated that topical oxymetazoline is effective in management of allergic and non-infectious conjunctivitis,, and it blocks histamine induced hyperaemia. We compared the efficacy of 0.01% oxymetazoline, 0.01% xylometazoline 0.01% naphazaline and 0.01% phenylephrine in counteracting histamine induced conjunctival hyperaemia, in the rabbits. Oxymetazoline proved to be more efficacious, with longer acting and was the only decongestant which was prophylactic against histamine induced hyperaemia. Encouraged by this study, we designed a prospective double blind study on the use of topical 0.01% oxymetazoline in benign red eyes. To the best of knowledge, ours is the first clinical report on the use of 0.01% oxymetazoline in benign red eyes.
| Material and methods|| |
Total of 50 patients (36 males, 14 females) were selected randomly for the present study after ruling out any possible infective etiology. There were seven patients who did not complete the follow up and were excluded. Detailed ocular examination was performed by the same observer on the initial and follow up visits. This included recording of vision (both for near and distance), pupil size, depth of anterior chamber, near point of accommodation, intraocular pressure and schirmer's test values. Systemic blood pressure, heart rate and pulse rate were also recorded at each visit.
Symptoms and signs were evaluated on a 4 point scale (0=none, l=mild, 2=moderate 3=severe).
Criteria for exclusion were involvement of episcleral vessels, vernal catarrh, pregnancy, allergy to oxymetazoline or its vehicle, concurrent topical medication and disease in which sympathomimetic are contraindicated. 0.01% oxymatazoline in boric acid buffer in one eye and the placebo (boric acid buffer) in the other were prescribed q i d. The drops were coded and the code was broken on the completion of study. Patients were re-examined at 30 minutes after instillation of the drops and then were followed up on 3rd and 10th day when the study was discontinued.
Duration of action of topical 0.01% oxy metazoline was studied in six patients. Two drops of oxymatazoline were instilled in one eye and two placebo drops in the control, contralateral eye and the patients were examined every hour. End point was base level or equal congestion in both eyes. Patients were further observed for two hours to note the phenomenon of rebound hyperaemia if any.
For the purpose of analysis average mean score of each of the studied parameter was calculated The average mean score of -the placebo and oxymetazoline treated eyes at each examination was compared with the average mean score of each eye 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. P-values were calculated from the standard X 9 test.
| Observations|| |
Of the 50 patients with benign red eyes 36 were males and 14 females with age range from 14 to 60 years.
0.01% topical oxymetazoline proved to be effective ocular decongestant [Figure - 1].
After 30 minutes of instillation all symptoms were uniformly relieved and improvement in hyperaemia was 87.5% [Figure - 2]. But interestingly improvement in placebo group at 30 minutes was 50%. We feel this may not be truly reflective because of previous detailed ocular examination which involved xylocaine instillation and eye-instrument touch, Concomitantly in the placebo group mean scores for foreign body sensation and watering went up from the base line mean scores [Table - 1]. Our data for the 3rd and 10th day of examination is uniform in showing both statistically significant subjective and objuctive improvement with 0.01% oxymetazoline. Percentage of symptomatic improvement in oxymetazoline group was 69.93% as compared with 33.16% for the placebo group (p<0.05). Objective improvement of vasocongestion, which could be considered a more reliable indicator of effectivity also showed oxymatazoline to be highly effective (p<0.05)[Table - 2].
Study on the duration of action of oxymetazoline revealed its long duration of action (8.33±0.42 hrs mean ± S.E.M,) and no rebound hyperaemia was observed [Figure - 3].
No side effects were observed during the entire study. Pupil size, intraocular pressure, near point of accommodation and Schirmer's test values remained unaffected. There was no significant changes in pulse or heart rate and pressure.
| Discussion|| |
Naphazoline hydrochloride is the most widely used ocular decongestant but sedation has been reported with its use and it causes moderate rebound vasodilation in histamine induced hyperaemia in rabbits. 0.01% oxymetazoline caused no rebound hyperaemia and was the only effective prophylactic to histamine induced hyperaemia. Oxymetazoline has been shown to possess statictically significant decongestant effect in allergic and non-infectious conjunctivitis(34). Duzan et a1 found 0.025% to be the optimum concentration for topical use. These investigators also found that oxymetazoline remained primarily in the extraocular tissue and its effect was still evident 4-5 hours after topical administration. Our studies demonstrate that 0.01% oxymetazoline retains its effect for al teast 8 hours and shows no annoying rebound hyperaemia. Pupil size. intraocular pressure, near point of accommodation and blood pressure did not change significantly from base line values as has been reported in previous studies(18). Once the physician is certain that red eye do not represent a pathalogic disease process, vasoconstrictors become an option. The use of sympathetic vasoconstrictors and antihistaminics to relieve conjunctival hyperaemia is wide spread and well accepted. Because of its quick onset, prolonged effective action and lack of side effects, we feel that 0.01% oxemetazoline is a suitable decongestant for topical use in benign red eyes and offers advantages over currently available vasoconstrictors and is a rational alternative to topical steroids. Currently a comparative clinical trial of oxymetazoline with naphzoline is in progress.
| Acknowledgement|| |
The authors are thankful to E. Merck (India) Ltd. for providing oxymetazoline hydrochloride.
| References|| |
Abelson MB, Yamamoto GK. Allansmith MR : 1980: Arch. Ophthalmol 98 : 856-858.
Cowen DE : 1966 Ear Nose Throat: 45 : 58-61.
Fox SL. Samson CR, Denzig MR : 1979 J. Int. Med. Res. : 5 : 528.530.
Breakey AS, Cinnoti AA, Hirshman M, Skowroh RA, Samson CR, Denzig MR : 1980: Pharmacotherapeutica. 2 : 353-356.
Hurwitz P, Thompson JM : 1950: Arch. Ophthalmol. 43: 712-717.
Duzman E, Anderson J, Vita JB, Bue JC, 1983: Arch. Ophthalmol 101 :1122-1126.
Gupta SK, Uppal RK, Vajpayee RB : 1985 Int. Symp. Ocul Pharm. Jan. N. Delhi. 40-45.
Samson CR, Denzig MR, Sasovetaz LD, Thompson HS : 1980 : Pharmacotheapeutica. 2: 347-350.
Millar J and Wolf EH : 1975: Annals of Allergy. 35 :81-86.
[Figure - 1], [Figure - 2], [Figure - 3]
[Table - 1], [Table - 2]