Abstract
A MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, ACTIVE CONTROL, PARALLEL GROUP, COMPARATIVE STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF REBAMIPIDE OPHTHALMIC SUSPENSION 2.0% W/V VS. SODIUM HYALURONATE OPHTHALMIC SOLUTION 0.1% W/V FOR THE TREATMEN

*Dr. Shailesh Singh, Dr. Ravindra Mote, Dr. Sarita Shukla, Mr. Vijay Kranti and Khushwant Khatri

ABSTRACT

Background: The present study was designed to evaluate the efficacy, safety and tolerability of Rebamipide Ophthalmic Suspension 2.0% w/v (Arm A) Vs. Sodium Hyaluronate Ophthalmic Solution 0.1% w/v (Arm B) in patients suffering from Dry Eye. The main objective of the study was to compare patient-perceived relief from the symptoms of foreign body sensation, dryness, photophobia, eye pain, blurred vision. Method: It was a comparative, randomized, double blind, parallel group, active control, multi-centric clinical trial conducted in 8 centers across India in patients with signs and symptoms of dry eye. The recruitment has been start from Jun 09, 2015 to Mar 16, 2016. Total 236 patients (aged 18 – 65 years) were randomized in the ratio of 1:1 in both arms. All the patients were advised to instil one drop four times daily in affected eye of either Rebamipide Ophthalmic Suspension 2.0% w/v or Sodium Hyaluronate Ophthalmic Solution 0.1 % w/v as per randomization. The treatment continued for 168 days with periodic follow-up on 28th, 56th, 84th, 112th, 140th and 168th days from start of treatment. Results: The current study showed the Mean change in Fluorescein Corneal staining score from baseline to visit 7 for Rebamipide Ophthalmic Suspension 2.0% w/v and Sodium Hyaluronate Ophthalmic Solution 0.1% w/v as – 2.15 and – 1.9 respectively. There were 15 clinical adverse events reported (Rebamipide: 06, Sodium Hyaluronate: 09) in the study and which were mild and transient in nature. Conclusion: Rebamipide Ophthalmic Suspension 2.0% w/v has higher efficacy of improving clinical features of dry eye when compared with Sodium Hyaluronate Ophthalmic Solution 0.1% w/v and as safe as Sodium Hyaluronate Ophthalmic Solution 0.1% w/v.

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