[Comparison of once-daily nonpreserved timolol and timolol maleate gel-forming solution associated with latanoprost].
OBJECTIVE
To compare the efficacy and safety of a single daily instillation of nonpreserved timolol to a timolol maleate gel-forming solution in patients with chronic glaucoma or ocular hypertension already treated with latanoprost.


METHODS
A randomized, prospective, multicenter, open, parallel-group clinical trial was undertaken with 73 patients with chronic glaucoma treated with latanoprost and a timolol maleate gel-forming solution. In 36 patients, the previous regimen was substituted by nonpreserved timolol given instead of timolol maleate gel for 3 months. The changes in intraocular pressure (IOP) were recorded as well as local and systemic tolerance and patient compliance.


RESULTS
At 3 months, both regimens were found equivalent in maintaining IOP control between D0 and D84. The difference with baseline was -0.08 +/- 2.22 mmHg and -0.38 +/- 2.41 mmHg in the nonpreserved timolol group and in the timolol maleate gel-forming solution group, respectively (CI 95% [-0.79; 1.38]). After 84 days of treatment, blurred vision (5.9%) and eyelid deposits (5.9%) were reduced in the preservative-free timolol group compared to the other group (respectively, 33.3% and 24.2%). These differences were statistically significant for both signs (blurred vision: p < 0.0001 and for eyelid deposits: p = 0.03).


CONCLUSIONS
This short-term study has demonstrated the equivalence of nonpreserved timolol to timolol maleate gel-forming solution in terms of IOP control. Moreover, the local tolerance of nonpreserved timolol was better.
Bron
A
A
Service d'Ophtalmologie, CHU de Dijon, Hôpital Général, 3, rue du Faubourg Raines, BP 1519, 21033 Dijon Cedex, France. Alain.bron@CHU-Dijon.fr
Velasque
L
L
Rebica
H
H
Pouliquen
P
P
Elena
P-P
PP
Rouland
J-F
JF
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage*; D013997:Time Factors; D013999:Timolol / Q000008:administration & dosage*
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; D013999:Timolol