Table 1.

The inclusion and exclusion criteria of our study patients

Inclusion criteria

• Patients’ age ≥21 with ocular hypertension or open-angle glaucoma and not on active glaucoma treatment

• Patients with IOP of ≥24 and ≤34 mmHg in each eye, at baseline (day 0) hour 0 (T0); and IOP of ≥22 and ≤34 mmHg in each eye in 2 h (T0+2 h) and 8 h time (T0+8 h)

• Patients with BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart

Exclusion criteria

• Known or suspected allergy to travoprost or to any component of the study product

• IOP of >34 mmHg in either eye at any time point during study period

• CCT <460 or >620 μm

• Patients with advanced glaucomatous changes, including cup-to-disc ratio >0.80 (horizontal or vertical measurement, severe central visual field loss, or documented significant progression of a visual field defect during the recruitment period)

• Difficulty of OTX-TP insertion due to presence of punctum or lacrimal drainage (canaliculus, lacrimal sac, nasolacrimal duct) anomalies

• History of inadequate response to treatment with prostaglandins

• History of ocular trauma, laser surgery, or previous intraocular surgery within the past 6 months in either eye

• History of ocular infection or ocular inflammation within 3 months prior to the study in either eye, severe dry eyes, active epiphora, active blepharitis, aniridia, retinal detachment, and diabetic retinopathy

• Use of any topical glaucoma or nonglaucoma eye drops or systemic ocular hypertensive medication at baseline or during the study period

• Use of any systemic corticosteroids (not including inhaled or nasal steroids) within 4 weeks prior to the study

• Use of contact lenses at any point during the study

• Pregnant or breast-feeding women or women who wish to become pregnant during the time of study participation

• Any subject is deemed not to be suitable by the clinician for reasons not already specified (eg, systemic or other ocular disease/abnormality)

Abbreviations: IOP, intraocular pressure; BCVA, best corrected visual acuity; CCT, central corneal thickness; OTX-TP, travoprost punctum plug; ETDRS, Early Treatment Diabetic Retinopathy Study; logMAR, logarithm of the minimum angle of resolution.