Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis

Abstract

Objective:

To evaluate the clinical efficacy and safety of tobramycin/dexamethasone (TobraDex ST^*; ‘ST’) ophthalmic suspension 0.3%/0.05% compared to azithromycin (Azasite^†) ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis.

Research design and methods:

The study was a multicenter, randomized, investigator-masked, and active-controlled, 15-day study. Enrolled in the study were 122 adult subjects (at least 18 years of age) diagnosed with moderate to severe blepharitis/blepharoconjunctivitis, defined by a minimum score of at least ‘1’ for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye and a minimum global score (total signs and symptoms score) of ‘5’ in the same eye. One group of 61 subjects received ST with instructions to dose 1 drop four times daily (QID) for 14 days. The other group of 61 subjects received azithromycin and dosed with 1 drop twice daily (BID) for 2 days followed by once daily (QD) dosing for 12 days. Visits were conducted at Day 1 (baseline), Day 8 and Day 15. The a priori primary outcome parameter of the study was the seven-item global score defined as the total score of lid margin redness, bulbar conjunctival redness, palpebral conjunctival redness, ocular discharge (0–3 scale), and lid swelling, itchy eyelids, and gritty eyes (0–4 scale). The study utilized standardized, validated photograph control scales developed by Ora, Inc. (Andover, MA).

Clinical trial registration:

Trial registration: ClinicalTrials.gov identifier: NCT01102244.

Results:

A statistically significant lower mean global score (p = 0.0002) was observed in subjects treated with ST compared to subjects treated with azithromycin at Day 8. No serious adverse events were reported during the course of the study in either group.

Conclusion:

ST provides a fast and effective treatment of acute blepharitis compared to azithromycin. Initial therapy with the combination of tobramycin/dexamethasone provides faster inflammation relief than azithromycin for moderate to severe blepharitis/blepharoconjunctivitis.

Key words::

• Anti-infective
• Anti-inflammatory
• Clinical trial
• Dexamethasone
• Ophthalmic
• Tobramycin

Transparency

Declaration of funding

The study, publication and data presentations were supported by funding from, and sponsored by, Alcon Laboratories, Fort Worth, TX, USA.

Declaration of financial/other relationships

The authors report no conflicts of interest in this work. P.C. has disclosed that he is an employee of Alcon. E.M., W.H., B.S. and S.S. have disclosed that they were principal investigators for the study and received grant funding from Alcon to support the research study.

Acknowledgments

The authors thank Aron Shapiro (Vice President, Anti-infectives and Anti-inflammatories at Ora, Inc.) and Mark Abelson, MD, CM, FRCSC (Associate Clinical Professor of Ophthalmology at Harvard Medical School, Senior Clinical Scientist at Schepens Eye Research Institute and CSO at Ora, Inc.) who designed, managed and conducted the clinical study. The authors also thank Stephen S. Lane, MD and Richard L. Lindstrom, MD for critical review of this manuscript, and Kathryn Kennedy (Statistics & Data Corporation, Tempe, AZ, USA) for data management and statistics.

Notes

* TobraDex is a registered trade name of Alcon Research Ltd, Fort Worth, TX, USA.

† Azasite is a registered trade name of Inspire Pharmaceuticals, Durham, NC, USA.

* TobraDex is a registered trade name of Alcon Research Ltd, Fort Worth, TX, USA.

† Azasite is a registered trade name of Inspire Pharmaceuticals, Durham, NC, USA.