Efficacy of Tafluprost as an Adjunct to Medical Therapy for Residual Glaucoma After Trabeculectomy

NCT03595865 | Unknown

• 1 other identifier: TPLS2018G
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A 6-month, parallel-group study of the safety and efficacy of tafluprostin for Chinese patients with posttrabeculectomy residual primary angle-closure glaucoma or posttrabeculectomy residual primary open angle glaucoma.

Conditions

Glaucoma; Drugs

Outcome Measures

Primary Outcomes (1)

• IOP

  The IOP will be measured at 1, 2, 3, 4, 5, and 6 month visit. All IOP measurements are to be performed at about the same time of day (at 9 AM at each visit). After topical anesthesia and conjunctiva sac stained byfluorescence, IOP was measured by Goldmann tonometer. The IOP value was the mean of 3 consecutive measurements.

  6 months

Study Arms (2)

residual primary open angle glaucoma

EXPERIMENTAL

Each eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months

Drug: tafluprostin

residual primary angle-closure glaucoma

EXPERIMENTAL

Each eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months

Drug: tafluprostin

Interventions

tafluprostin DRUG

Both patients in PACG and POAG groups will dose 1 time daily in each eye for 6months. Each eye will be preformed tafluprostin 0.0015% at 9 PM.

residual primary angle-closure glaucoma; residual primary open angle glaucoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergone trabeculectomy at least 30 days a mean intraocular pressure (IOP) between 21 and 35mmHg documented residual PACG/POAG after trabeculectomy visual acuity was more than 0.1

You may not qualify if:

• women who were of childbearing potential (not postmenopausal or surgically sterile), pregnant, or nursing previous ocular mechanical trauma ocular infection or ocular inflammation any abnormality preventing reliable applanation tonometry of either eye cannot be safely discontinued from use of all ocular hypotensive medication(s) for a minimum period of 5 days to a maximum period of 4 weeks best-corrected visual acuity worse than 1.0 logMAR in study eye wore contact lenses refractive surgery or intraocular surgery within past 3 months severe or serious hypersensitivity to prostaglandins, prostaglandin analogs, or to any components of the study medications severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease less than 1 month stable dosing regimen of any medication used on a chronic basis that could affect IOP use of steroid or nonsteroid anti-inflammatory drug within 1 month therapy with another investigational agent within the past 30 days with other abnormal ocular condition or symptom preventing the patient from participating in the study

Sponsors & Collaborators

• wangdabo: lead

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 23, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 23, 2018

Record last verified: 2018-07