Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT

NCT01895972 | Completed Phase 3 Results

• 1 other identifier: 811
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Intraocular Pressure

  Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.

  Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

• Clinical Safety

  Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.

  1 year

Study Arms (1)

Latanoprostene Bunod

EXPERIMENTAL

Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

Drug: Latanoprostene bunod

Interventions

Latanoprostene bunod DRUG

Also known as: BOL-303259-X

Latanoprostene Bunod

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

• Kawase K, Vittitow JL, Weinreb RN, Araie M; JUPITER Study Group. Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study. Adv Ther. 2016 Sep;33(9):1612-27. doi: 10.1007/s12325-016-0385-7. Epub 2016 Jul 25.

  PMID: 27457469 RESULT

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

BOL 303259-X

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: H. DeCory, Director Medical Affairs
• Organization: Bausch + Lomb, a division of Valeant Pharmaceuticals

heleen_H_decory@bausch.com

585 732-3284

Study Officials

• Jason L. Vittitow, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 11, 2013
• Study Start: July 5, 2013
• Primary Completion: April 2, 2015
• Study Completion: April 14, 2015
• Last Updated: July 26, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-06

Locations

US (1)