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Accommodation of Three Regimens of Topical Dapiprazole Br J Ophthalmol: First Published As 10.1136/Bjo.79.6.544 on 1 June 1995

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Accommodation of Three Regimens of Topical Dapiprazole Br J Ophthalmol: First Published As 10.1136/Bjo.79.6.544 on 1 June 1995 544 British Journal of Ophthalmology 1995; 79: 544-548 Comparison of the effects on pupil size and accommodation of three regimens of topical dapiprazole Br J Ophthalmol: first published as 10.1136/bjo.79.6.544 on 1 June 1995. Downloaded from Charles S Wilcox, Jon F Heiser, Anna Mae Crowder, Nancy J Wassom, Barbara B Katz, Jacqueline L Dale Abstract mydriasis induced by sympathomimetic Background-Patients who have their agents, such as phenylephrine, and parasympa- pupils dilated for an eye examination tra- tholytics, such as tropicamide, dapiprazole also ditionally have to wait several hours shows a beneficial effect on loss of accommo- before their pupils return to normal size dation,1 although the exact mechanism for its and their blurred vision (caused by paral- effect on accommodation is unknown. In most ysis of accommodation) resolves. Earlier patients, reversal of mydriasis and improve- studies with dapiprazole have demon- ment in accommodation begin within 15 strated an accelerated reversal of dilata- minutes of administration of the drug. tion. Since its introduction, dapiprazole has been Methods-Three regimens of dapiprazole used in a 2+2 regimen, two drops followed by were studied to determine the effects on two more drops 5 minutes later. In clinical pupil diameter and accommodation after practice, returning to dose the patient for a mydriasis produced by 2.5% phenyl- second time in 5 minutes can sometimes be ephrine and 0.5% tropicamide. Test troublesome for both the ophthalmologist and regimens included one drop and 1 + 1 the patient. After a review of the literature on drop regimens, compared with a 2 +2 drop dapiprazole, Doughty and Lyle2 suggested that reference regimen. Dapiprazole was further studies should be conducted to investi- administered in one eye and placebo in gate the optimum dosing regimen. In addition, the other. Mean change from baseline was the capacity of the cul de sac has been esti- analysed for pupil diameter and accom- mated as 0-025 ml,3 suggesting that significant modation at various time points after washout of a two drop dose may occur; fur- drug administration. Also, for the same thermore, known side effects of dapiprazole variables, 900/o confidence intervals for the may also be reduced by a regimen with fewer http://bjo.bmj.com/ areas under the curve (AUC) were com- drops. puted. This study explored the comparative efficacy Results-Both test regimens were equiva- of three regimens of dapiprazole. Regimens lent to the reference regimen on the basis were compared with respect to reversal of of mean change from baseline for pupil mydriasis, improvement in accommodation, diameter and accommodation at individ- and incidence of side effects. Known eye ual time points, and for the mean AUC. colour effects (slower reversal of mydriasis in Most signs and symptoms (injection, patients with dark irides) were controlled for in on October 2, 2021 by guest. Protected copyright. stinging, burning, lid oedema, and ptosis) the experimental design. were less frequent in the test regimen treated eyes. There was no significant interaction between regimen and eye STUDY OBJECTIVE colour. The objective of this study was to demonstrate Conclusion-This study indicates that a the equivalence of two test regimens to a 'ref- lower dosage (for example, one drop) is erence' regimen of 0-5% dapiprazole in their also efficacious and has the added benefit ability to reverse mydriasis induced by 2-5% offewer side effects. phenylephrine (Neosynephrine, Winthrop) (BrJ Ophthalmol 1995; 79: 544-548) and 05% tropicamide (Bausch and Lomb). A Pharmacology secondary objective was to evaluate and com- Research Institute, pare the subject's ability to tolerate the three Irvine, California, Dapiprazole 0-5% (Rev-Eyes; Angelini regimens. No previous study had compared USA C S Wilcox Pharmaceuticals Inc. Rev-Eyes is manufac- the effects of different regimens of 05% J F Heiser tured by Abbott Laboratories and marketed by dapiprazole. A M Crowder Storz Ophthalmics Inc) was introduced in the N J Wassom United States in 1991 in response to the need BB Katz JL Dale for a convenient method of reversing iatro- Materials and methods genically induced mydriasis. Dapiprazole is an A clinically significant mean change from base- Correspondence to: Charles S Wilcox, PhD, a adrenergic blocking agent administered line for pupil diameter, between reference and 19712 MacArthur topically. Its chemical formula is 5,6,7,8- test compounds, was 0 5 mm. Data from a Boulevard, Suite 220, Irvine, CA 92715-2407, USA. tetrahydro-3-[2-(4-o-tolyl-1-piperazinyl) ethyl]- previous study indicated a within (intra) sub- Accepted for publication s-triazolo [4,3-a] pyridine hydrochloride. ject variance of 0O81. The computed sample 26 January 1995 While its primary action is the reversal of size was 55 subjects. In order to allocate an Comparison ofthe effects on pupil size and accommodation ofthree regimens oftopical dapiprazole 545 equal number of subjects to three regimens, a Prince rule, a line that was visible at that sample size of 60 was chosen. distance was identified and recorded (for This was a double masked, placebo con- example, 20/40 at 50 cm). trolled, crossover study. Subjects participated Corrected visual acuity was measured using Br J Ophthalmol: first published as 10.1136/bjo.79.6.544 on 1 June 1995. Downloaded from in three study sessions, each at least 5 days the standard Snellen chart at 20 feet. Safety apart. Treatment sequence group and the eye was assessed by recording signs and symptoms to be treated were randomised and balanced of the external eye and periocular tissues. The within eye colour (brown or other). After base- severity of adverse events and their relation to line examinations, each subject had both eyes the study drug were routinely recorded in a dilated with 2-5% phenylephrine and 0 5% standardised manner. tropicamide. After 1 hour, one eye was treated The baseline measurements used for com- with one ofthree dapiprazole regimens and the parison of pupil diameter and accommodation other eye was treated with placebo (the inac- between the test regimens and the reference tive ingredients of the dapiprazole formula- regimen were the pre-mydriasis measure- tion). The three regimens are: one drop ('1' ments. Pupil diameter and accommodation drop test regimen); one drop plus one drop 5 were measured at baseline, 0, 15, and 30 min- minutes later ('1 + 1' drop test regimen); two utes and at 1, 2, 4, and 6 hours after treatment drops plus two drops 5 minutes later ('2+2' with dapiprazole or placebo. drops reference regimen). The primary efficacy variable was mean To ensure masking of the investigator, pupil diameter change from baseline. A preparation and administration of study regi- clinically significant difference between regi- mens were performed by an individual who mens at individual time points was >'0 5 mm. was not involved in subsequent evaluations. Mean change from baseline was expressed as a Baseline examinations included general positive number, since the pupil size increased medical and ocular histories. An external after the mydriatic was administered. A ophthalmic examination and a slit-lamp secondary efficacy variable was mean accom- examination of the anterior segment of the eye modation loss from baseline. A clinically sig- were also conducted, along with pupil diame- nificant difference between regimens at ter, distance visual acuity, and near point of individual time points was defined as > 1 accommodation. Throughout the study the dioptre. Mean change from baseline was measurements of pupil diameter, distance expressed as a negative number, since accom- visual acuity, and near point of accommoda- modation decreased after the cycloplegic was tion were performed before (hour 0) and after administered. instillation of the study drug at time points Area under the curve (AUC) for mean pupil ranging from 15 minutes after administration diameter was computed from 0 hours (pre- to 6 hours. mydriasis) to 6 hours (post treatment). The In all measurements, the right eye was AUC was computed in mmXh. A clinically sig- evaluated first and then the left eye. Pupil nificant difference between regimens for AUC diameter was measured by having subjects was 3 mmXh (0 5 mm X6 hours). Likewise, http://bjo.bmj.com/ focus on a visual chart at a distance of 20 feet, AUC for mean accommodation was computed and horizontal pupil measurement was taken from 0 to 6 hours. The AUC was computer in to the nearest 0 5 mm using a pupillometric Dxh. A clinically significant difference scale; all measurements were performed by between regimens for AUC was 6 Dxh (1 D the same licensed clinician, using a standard x6 hours).* (Bausch and Lomb) pupil diameter gauge. The examination rooms used standardised ambient on October 2, 2021 by guest. Protected copyright. illumination. 5.5 Near point of accommodation was o 2 + 2 drops mean measured with the subject corrected for dis- A 1 + 1 drop mean tance. The Prince rule was attached to the 4.5 o 1 drop mean phoropter. The Prince rule is a device for * Untreated eye determining the near point and amplitude of accommodation, consisting of a steel tape scaled in dioptres on one side and in milli- E metres on the other. One end of the tape is held against the lower orbital margin, and a co E test chart is moved along the tape, towards the eye, until a blur is noticed.4 The 20/30 reduced Snellen line on the Rosenbaum pocket vision CL c screener card (for example, a reduced Snellen o. chart for near vision) was used. The card was positioned at the closest distance to the eye and then moved away until the subject could read the 20/30 line. This step was performed three *The mean AUC in Dxh is times at all measurements (however, in one reported for treated eyes for -1.5 each of the three dapiprazole instance it was inadvertently done only once at 0 regimen groups.
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