[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial].

OBJECTIVE

To realize the effectiveness and security of Tobramycin and Dexamethasone Eye Ointment for blepharitis treatment. Design Case control studies. Participants 148 patients be diagnosed as blepharitis including 81 cases as research group and 67 cases as control group.

METHODS

Multi-center randomized controlled clinical trial. The patients met the inclusion criteria from First Hospital Peking University, Beijing Tongren Hospital, Southwest Hospital, Ophthalmology Center Zhongshan University and Third Hospital Peking University were divided into two groups in Aug. to Dec. 2011. Tobramycin dexamethasone eye ointment was applied to eye lid in research group while patients in control group used tobramycin eye ointment. All patients were informed to apply warm compress to the lids, mechanically washing to the eyelids and artificial tears. At the beginning, the 7(th) day, the 14(th) day and the 28(th) day of treatment, observation of symptom, sign and side effect were recorded.

RESULTS

Before treatment the difference of the symptom scores of burning sensation, tears, photophobia and itch of two groups has no statistically significant (t = 1.87, 0.43, -0.64, 0.93, P > 0.05), but the symptom scores have a statistically significant decrease (t = 1.99 - 6.90, P < 0.05) at the 7(th) day, 14(th) day, 28(th) day. Before treatment the difference of signs scores have no statistically significant except the term of new blood vessels (t = 2.32, P = 0.02) while all the signs scores have a statistically significant decrease at the 7(th) day, 14(th) day, 28(th) day. Side effect: the number of patients with elevated intraocular pressure of research and control group is 3 and 1 respectively and the ratio is 3.7% and 1.5%.

CONCLUSIONS

The tobramycin dexamethasone eye ointment can improve signs and symptoms of blepharitis patients. Some patients have to face with the risk of elevated intraocular pressure and it's necessary to monitor the intraocular pressure.