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Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ocular Hypertension; Open-angle Glaucoma

Intervention: Travoprost ophthalmic solution (new formulation) (Drug); Travoprost ophthalmic solution, 0.004% (Drug); Vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Theresa Landry, PhD, Study Director, Affiliation: Alcon Research

Summary

The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.

Clinical Details

Official title: Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean change from baseline in intraocular pressure (IOP)

Secondary outcome:

Mean intraocular pressure

Mean percent change from baseline in IOP

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Satisfy all informed consent requirements;

- Diagnosed with open-angle glaucoma or ocular hypertension;

- Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28

days prior to the Eligibility 1 Visit;

- IOP measurements in at least 1 eye as specified in protocol;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Females of childbearing potential if pregnant, breastfeeding, or not using highly

effective birth control measures;

- Any form of glaucoma other than open-angle glaucoma;

- Severe central visual field loss in either eye;

- Chronic, recurrent or severe inflammatory eye disease;

- Clinically relevant or progressive retinal disease such as retinal degeneration,

diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;

- Best-corrected visual acuity (BCVA) worse than 0. 60 logarithm of the miniminum angle

of resolution (logMAR);

- Intraocular surgery within the past 6 months;

- Ocular laser surgery within the past 3 months;

- Any abnormality preventing reliable applanation tonometry;

- Severe illness or any other conditions which would make the patient, in the opinion

of the Investigator, unsuitable for the study;

- Other protocol-specified exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: April 2008
Last updated: July 9, 2014

Page last updated: August 23, 2015

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