A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances

Table 1 Demographic variables and baseline measurements

Demographic variable	Placebo	1.0% Phentolamine	P-value^a
Sample Size	8 (100%)	16 (100%)	–
Female (%)	5 (63%)	12 (75%)	.68
Mean age (yrs ± STDEV)	47.4 ± 13.5	42.1 ± 14.6	.40
Night vision complaints
Halos	7 (87.5%)	9 (56.3%)	.35
Glare Sensitivity	7 (87.5%)	15 (93.8%)	1.0
Starbursts	5 (62.5%)	11 (68.8%)	1.0
Depth Perception	5 (62.5%)	11 (68.8%)	1.0
Other Concerns	0 (0%)	0 (0%)	NA
Intraocular pressure
Right Eye (mm Hg ± STDEV)	13.8 ± 1.5	13.8 ± 2.7	NA
Left Eye (mm Hg ± STDEV)	13.4 ± 1.3	13.9 ± 1.4	.41
Blood pressure
Systolic (mm Hg ± STDEV)	124.8 ± 13.2	122.8 ± 11.2	.70
Diastolic (mm Hg ± STDEV)	79.8 ± 8.0	81.1 ± 8.7	.73
Prior vision surgery
LASIK, n (%)	2 (25.0%)	1 (6.3%)	.25
PRK, n (%)	0 (0%)	0 (0%)	NA
RK, n (%)	1 (12.5%)	0 (0%)	.33
Pupil diameter
Pre-illumination (mm ± STDEV)	6.6 ± 1.0	6.1 ± 1.7	.52
Illuminated (mm ± STDEV)	4.9 ± 0.8	4.4 ± 0.6	.10
Low contrast visual acuity^b
Pre-illumination (letters ± STDEV)	18 ± 9.4	21 ± 6.7	.46
Contralateral- illuminated (letters ± STDEV)	30 ± 8.4	33 ± 5.4	.30

Abbreviations: STDEV Standard Deviation, PRK Photorefractive keratectomy, RK Radial Keratotomy
^ap-values are from two-tailed, two-sampled t-tests for continuous variables and Fisher Exact tests for count variables
^b18 letters read is equivalent to 20/63. 30 letters read is equivalent to 20/40 + 2

ISSN: 1471-2415