Prophylactic Effectiveness of Tobramycin-Dexamethasone Eye Drops Compared with Tobramycin/Vehicle Eye Drops in Controlling Post-Surgical Inflammation in Cataract Patients

Ricardo Notivol; Dina Amin; Anna Whitling; David Wells; Margaret Kennedy; Paul C. Cockrum; The International TobraDex Study Group

Disclosures

Clin Drug Invest. 2004;24(9)

Conclusion

TobraDex®, when administered the day before and continued for 21 days after surgery, was superior to Tobrex®/vehicle in controlling post-cataract surgical inflammation. TobraDex® was also superior to Tobrex®/vehicle in controlling post-surgical ocular pain, and when administered four times daily was safe and well tolerated in patients treated for the prevention of post-surgical inflammation after cataract surgery.

The use of trade names is for product identification purposes only and does not imply endorsement.

1 2 3 4 5

Next Section

Acknowledgments

We thank Marta Pulido, MD, for editing the manuscript and for editorial assistance.

Members of the International TobraDex® Study Group: R. Belfort Jr, São Paulo, R. Cohen, Santa Casa de São Paulo, C.E.L. Arieta, Universidade de Campinas, Campinas, São Paulo, R.C.S. Seixas, School of Medicine ABC-SP, Santo André, São Paulo, and P.G. Neto, Santa Casa do Rio de Janeiro, Rio de Janeiro, Brazil; J.J. De Laey, Universitair Ziekenhuis Dienst Oogheelkunde, Gent, and M.J. Tassignon, Universitair Ziekenhuis Dienst Oogheelkunde, Edegem, Belgium; L. Collum, Royal Victoria Eye and Ear Hospital, C.O'Brien, Mater Hospital, Dublin, and E. O'Donoghue, University College Hospital, Galway, Ireland; M. Royo, Hospital del Aire, A. Arias, Fundación Hospital de Alcorcón, Universidad Rey Juan Carlos, J.M. Lorenzo, Hospital Universitario de La Princesa, Madrid, R. Barraquer, Clínica Barraquer, C. Ruiz-Lapuente, Clínica Oftalmológica, and J. Cano, Hospital Municipal de Badalona, Barcelona, Spain; C. Lobo, Hospital Universitario de Coimbra (AIBILI), Coimbra, Portugal; A. Behndig, Nirrland Universitetssjukhus, Umeå, Sweden; N. Schrage, Universitätsklinikum der RWTH, Aachen, B. Schmidl, Gemeinschaftspraxis, Bischofsheim, T. Wehler, Dillenburg, and S. Schmickler, Gemeinschaftspraxis, Ahaus, Germany.

Funding information

This study was financially supported by Alcon Research Ltd, Fort Worth, TX, USA.

Reprint Address

Dr Ricardo Notivol, Clinical Research Department, Alcon Cusí, Camil Fabra 58, E-08320 El Masnou, PO Box 2, Barcelona, SA, Spain. E-mail: ricardo.notivol@alconlabs.com.

Cite this: Prophylactic Effectiveness of Tobramycin-Dexamethasone Eye Drops Compared with Tobramycin/Vehicle Eye Drops in Controlling Post-Surgical Inflammation in Cataract Patients - Medscape - Sep 01, 2004.

Table I. Study design
Parameters	Period 1 (day -1 to day 7)					Period 2 (day 8 to day 21)
Parameters	Screening^a	Day -1	Day 0 (surgery)	Day 1	Day 3 ± 1	Day 8 ± 1	Day 14 ± 2	Day 21 ± 2
General information; medical history	X
Informed consent	X
Pregnancy test, when applicable^b	X							X
Peri-operative medication			X
Ocular surgery			X
Visual acuity	X	X		X	X	X	X	X
Slit-lamp examination	X	X		X	X	X	X	X
Fundus examination (dilated)	X							X
Intraocular pressure measurements	X	X		X	X	X	X	X
Physician's follow-up impression of inflammatory response				X	X	X	X	X
Dispense study medication^c		X				X
Collect study medication^d						X		X
Record adverse events		X	X	X	X	X	X	X
Complete exit form^d								X

Table II. Demographic data of the intent-to-treat patients (n = 401)
	TobraDex®	Tobrex®/vehicle	Total	p-Value
Age (y)
Mean	69.76	68.97	69.37	0.4616^a
SD	10.53	10.91	10.71
n	203	198	401
Sex (no.)				0.0266^b
Male	96	72	168
Female	107	126	233
Race (no.)				0.6129^b
Caucasian	195	191	386
Black	7	7	14
Asian	1		1
Iris colour (n)				0.3611^b
Brown	104	118	222
Blue	63	48	111
Hazel	18	13	31
Green	8	10	18
Grey	10	7	17
Missing		2	2

Table III. Patients discontinued from the study
Reason	TobraDex® (n = 211)	Tobrex®/vehicle (n = 206)	All randomised (n = 417)
Adverse event (related and unrelated to the study medication)	2	11	13
Lost to follow-up	0	2	2
Patient's decision to postpone surgery day	2	5	7
Noncompliance	4	1	5
Treatment failure	9	32	41
Other	6	10	16
Total	23 (11%)	61 (30%)	84 (20%)

Table IV. Patients excluded from per-protocol (PP) data set
Reasons leading to a patient's exclusion^a	TobraDex® (n = 211)	Tobrex®/vehicle (n = 206)	All randomised (n = 417)
Not receiving study drug	0	2	2
Did not meet inclusion criteria^b	13	8	21
History or evidence of ocular or systemic disease that would preclude participation in this study	4	10	14
Use of concomitant anti-inflammatory drugs	8	10	18
Diabetes mellitus	3	1	4
Study medication wrongly dispensed	1	0	1
No follow-up visit available after surgery (day 0)	6	3	9
Total^a	35	34	69
Total^a number of patients excluded from PP	32	32	64

Table V. Results of secondary efficacy variables in the per-protocol data set (mean ± SD)
Parameters/treatment group	Day
Parameters/treatment group	1	3	8	14	21
Cells
TobraDex®	1.20 ± 0.76	0.91^a ± 0.67	0.56^a ± 0.82	0.31^a ± 0.76	0.18^a ± 0.68
Tobrex®/vehicle	1.27 ± 0.82	1.36 ± 1.02	1.25 ± 1.11	0.96 ± 1.13	0.75 ± 1.18
Flare
TobraDex®	0.73 ± 0.89	0.43^a ± 0.70	0.23^a ± 0.66	0.18^a ± 0.63	0.13^a ± 0.59
Tobrex®/vehicle	0.71 ± 0.82	0.72 ± 0.91	0.74 ± 0.97	0.58 ± 0.97	0.50 ± 0.97
Ocular pain
TobraDex®	0.60^a ± 0.74	0.37^a ± 0.67	0.26^a ± 0.64	0.16^a ± 0.59	0.11^a ± 0.57
Tobrex®/vehicle	0.80 ± 0.91	0.92 ± 1.08	0.92 ± 1.16	0.68 ± 1.04	0.54 ± 1.00
Physician's impression of inflammation
TobraDex®	2.40 ± 1.02	1.78^a ± 0.98	1.29^a ± 1.13	0.81^a ± 1.17	0.49^a ± 1.15
Tobrex®/vehicle	2.48 ± 0.98	2.49 ± 1.20	2.46 ± 1.44	2.00 ± 1.63	1.55 ± 1.84

Table III. Patients discontinued from the study
Reason	TobraDex® (n = 211)	Tobrex®/vehicle (n = 206)	All randomised (n = 417)
Adverse event (related and unrelated to the study medication)	2	11	13
Lost to follow-up	0	2	2
Patient's decision to postpone surgery day	2	5	7
Noncompliance	4	1	5
Treatment failure	9	32	41
Other	6	10	16
Total	23 (11%)	61 (30%)	84 (20%)

Comments

Commenting is limited to medical professionals. To comment please Log-in.

Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....

Prophylactic Effectiveness of Tobramycin-Dexamethasone Eye Drops Compared with Tobramycin/Vehicle Eye Drops in Controlling Post-Surgical Inflammation in Cataract Patients

Conclusion

Tables

Tables

Tables

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

Comments

Email This

Feedback