Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan^® and Arulatan^®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial

Figures & data

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Patients with POAG or OH;
	IOP ≥21 mmHg at randomization visit;
	18 years or older; IOP from 21 to 36 mmHg after a 28-day washout period;
	Written informed consent to participate in the trial.
Exclusion criteria	Closed anterior chamber angle and secondary glaucomas; Pregnant or breastfeeding women; Severe central VF loss (defined as 2 of the 4 central fixation points of the 24–2 SITA VF test depressed to 10 dB or less); Patients unable to safely perform a 28-day washout period of the ocular hypotensive eyedrops; Chronic, severe or recurrent inflammatory eye diseases; Ocular trauma in the previous 6 months; Ocular infection or inflammation in the previous 3 months; Uncomplicated intraocular surgery in the previous 6 months; Uncomplicated ocular laser therapy in the previous 3 months; Corneal disease precluding reliable tonometry; Presence of clinically significant retinopathy; Concomitant use of topical or systemic corticosteroids;
	Severe clinical conditions that would make the patient ineligible for the study, according to the evaluator’s assessment.

Table 2 Comparison of clinical and demographic characteristics between groups

	ALT group (n=21)	XLT group (n=23)	P-value
Age (years)	65.3±9.4	61.9±10.9	0.30
Gender (%; F/M)	61.9/38.1	52.2/47.8	0.50
Race (Caucasian/Black/Others)	47.6/19.1/33.3	69.6/13/17.4	0.80
Mean baseline IOP (mmHg)	22.3±1.2	22.4±1.7	0.65

Note: Data given as mean±SD whenever indicated.

Abbreviations: ALT, Arulatan^®; XLT, xalatan^®; IOP, intraocular pressure; M, male; F, female.

Table 3 Comparison of IOP parameters between groups at all timepoints

	ALT group (n=21)	XLT group (n=23)	P-value
Mean IOP change from baseline (mmHg)
Baseline	–	–	–
2 weeks	8.0±2.3	7.7±2.4	0.69
6 weeks	8.3±2.0	8.5±2.1	0.70
12 weeks	7.9±2.5	7.9±2.0	0.60
Mean IOP (mmHg)
Baseline	22.3±1.2	22.4±1.7	0.65
2 weeks	14.3±2.3	14.6±2.8	0.90
6 weeks	14.0±2.4	13.5±2.2	0.30
12 weeks	14.4±3.0	14.6±1.8	0.46
Mean IOP treatment difference	−0.06
Mean IOP treatment difference 95% CI	[−0.97, 0.85]

Note: Data given as mean±SD whenever indicated.

Abbreviations: IOP, intraocular pressure; ALT, Arulatan^®; XLT, xalatan^®; CI, confidence interval.