Overview

This trial is active, not recruiting.

Conditions glaucoma, ocular hypertension
Treatment latanoprostene bunod
Phase phase 3
Sponsor Bausch & Lomb Incorporated
Start date July 2013
End date April 2015
Trial size 130 participants
Trial identifier NCT01895972, 811

Summary

The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
latanoprostene bunod BOL-303259-X

Primary Outcomes

Measure
Intraocular pressure
time frame: 1 year
Incidence of ocular adverse events (AEs)
time frame: 1 year
IOP (Change from baseline)
time frame: 1 year
Systemic AE's
time frame: 1 year

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma [NTG],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes. - Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0[after washout for the subjects already on treatment]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes. - Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes. Exclusion Criteria: - Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits. - Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug. - Subjects with a central corneal thickness greater than 600 μm in either eye. - Subjects with any condition that prevents reliable applanation tonometry in either eye. - Subjects with advanced glaucoma with a mean deviation (MD) < −12 dB, a history of split fixation, or a field loss threatening fixation in either eye. - Subjects with any condition that prevents clear visualization of the fundus. - Subjects who are monocular (fellow eye is absent). - Subjects with aphakia in either eye. - Subjects with an active corneal disease in either eye. - Subjects with severe dry eye in either eye. - Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye. - Subjects with very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye. - Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening). - Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening). - Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).

Additional Information

Official title A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Bausch & Lomb Incorporated.