Ocular hypotensive efficacy and safety of travoprost 0.004% in inadequately controlled primary open-angle glaucoma or ocular hypertension: short-term, multicenter, prospective study.
Curr Med Res Opin
; 25(1): 57-63, 2009 Jan.
Article
in En
| MEDLINE
| ID: mdl-19210139
ABSTRACT
OBJECTIVE:
To evaluate the intraocular pressure (IOP) lowering efficacy and safety of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension, poorly controlled with or intolerance to beta-blockers. To record the short-term effect on diastolic ocular perfusion pressure (DOPP). RESEARCH DESIGN ANDMETHODS:
One hundred and three patients with open-angle glaucoma or ocular hypertension were treated with travoprost 0.004% once daily for 90 days in an open-label, non-controlled study. Efficacy and safety were assessed at baseline, after 45 and 90 days. Clinical registry number IT0301. MAIN OUTCOMEMEASURES:
The primary outcome measure, IOP, was recorded at 10 am, 12 pm, and 4 pm at each visit. DOPP was evaluated at 10 am, at baseline and visit 3. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure.RESULTS:
Mean IOP was reduced from 22.2 +/- 1.7 mmHg to 16.5 +/- 2.1 after 45 days (p < 0.0001), and to 16.1 +/- 2.2 after 90 days (p < 0.0001). The DOPP increased by 5.3 +/- 6.3 mmHg after 90 days of treatment (p < 0.0001). No drug related serious adverse events were reported during the study.CONCLUSIONS:
The open-label and non-comparative nature of the study represented its principal limitations. The study confirmed the efficacy and tolerability of travoprost in the treatment of open-angle glaucoma or ocular hypertension, in a subset of patients unsuccessfully treated with beta-blockers. In this study, travoprost significantly increased DOPP at short-term follow-up. Further studies to assess the effect of travoprost on DOPP are warranted.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Glaucoma, Open-Angle
/
Ocular Hypertension
/
Cloprostenol
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Curr Med Res Opin
Year:
2009
Document type:
Article
Affiliation country:
Italy