Efficacy of Changing to TRAVATAN® From Prior Therapy

NCT01510145 | Completed Phase 4 Results

• 1 other identifier: RDG-10-300
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Open-angle glaucoma; Ocular hypertension; Hypertension; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Travoprost; Antihypertensive Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)

  IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

  Baseline, Week 12

Secondary Outcomes (1)

• Percentage of Subjects Who Reach Target IOP (≤18 mmHg)

  Week 12

Study Arms (1)

TRAVATAN® BAK-free

EXPERIMENTAL

Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.

Drug: Travoprost 0.004% BAK-free

Interventions

Travoprost 0.004% BAK-free DRUG

Containing Polyquad (PQ) preservative

Also known as: TRAVATAN® BAK-free

TRAVATAN® BAK-free

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
• On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
• Intraocular pressure (IOP) \<30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
• IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
• Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;
• Able to follow instructions and willing and able to attend all study visits;
• Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
• Must sign an informed consent form;

You may not qualify if:

• Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
• Any abnormality preventing reliable applanation tonometry in either eye;
• Corneal dystrophies in either eye;
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
• Any clinically significant, serious, or severe medical condition;
• Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
• Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
• Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit;
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment;
• Progressive retinal or optic nerve disease from any cause;
• Women who are pregnant, lactating, or not using reliable means of birth control;

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7.

  PMID: 26563363 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Hypertension; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Interventions

Travoprost

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Doug Hubatsch, Global Brand Leader, Medical Affairs
• Organization: Alcon Research, Ltd

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Adriana S. Bonadia

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 13, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-05