Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00761319
• Collaborator: (none)
• Enrollment: 705
• Arms: 2
• Duration (Months): 11

Study Details

Study Description

Brief Summary

The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 705 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost One drop self-administered in the study eye(s) once daily for 90 days	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.; Other Names: TRAVATAN Z®
Active Comparator: Latanoprost One drop self-administered in the study eye(s) once daily for 90 days	Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®); Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.; Other Names: XALATAN®

Outcome Measures

Primary Outcome Measures

1. Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score [Day 0, Day 90]

   The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.

Secondary Outcome Measures

1. Percentage of Patients With Corneal Fluorescein Staining Score = 0 [Day 90]

   The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older.

• Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.

• Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.

• Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.

• Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.

• Best corrected visual acuity of -0.6 logMAR or better in each eye.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.

• Use of contact lenses within 30 days of Visit 1.

• Use of contact lenses during the study.

• Participation in an investigational drug or device study within 30 days of entering this study.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00761319
• Other Study ID Numbers: C-08-047
• First Posted: Sep 29, 2008
• Last Update Posted: Apr 26, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Alcon Research: Open-angle glaucoma; ocular hypertension
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Patients were recruited from 78 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.
Pre-assignment Detail	705 patients were enrolled in this study. 701 patients were evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy visit (intent to treat): 652.

Arm/Group Title	Travoprost	Latanoprost
Arm/Group Description	One drop self-administered in the study eye(s) once daily for 90 days	One drop self-administered in the study eye(s) once daily for 90 days
Period Title: Overall Study
STARTED	353	352
COMPLETED	305	318
NOT COMPLETED	48	34

Baseline Characteristics

Arm/Group Title	Travoprost	Latanoprost	Total
Arm/Group Description	One drop self-administered in the study eye(s) once daily for 90 days	One drop self-administered in the study eye(s) once daily for 90 days	Total of all reporting groups
Overall Participants	318	334	652
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.3 (11.8)	66.3 (10.9)	66.3 (11.4)
Gender (participants) [Number]
Female	185 58.2%	216 64.7%	401 61.5%
Male	132 41.5%	118 35.3%	250 38.3%

Outcome Measures

1. Primary Outcome

Title	Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
Description	The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.
Time Frame	Day 0, Day 90

Outcome Measure Data

Analysis Population Description

Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.

Arm/Group Title	Travoprost	Latanoprost
Arm/Group Description	One drop self-administered in the study eye(s) once daily for 90 days	One drop self-administered in the study eye(s) once daily for 90 days
Measure Participants	305	314
Mean (Standard Error) [Units on a scale]	-9.1 (1.0)	-10.2 (0.9)

2. Secondary Outcome

Title	Percentage of Patients With Corneal Fluorescein Staining Score = 0
Description	The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.

Arm/Group Title	Travoprost	Latanoprost
Arm/Group Description	One drop self-administered in the study eye(s) once daily for 90 days	One drop self-administered in the study eye(s) once daily for 90 days
Measure Participants	306	318
Number [Percentage of patients]	37.6	38.7

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 22 October 2008 to 15 September 2009.
Adverse Event Reporting Description	This reporting group includes all patients who received the test article. Two patients experienced more than one adverse event.
Arm/Group Title	Travoprost		Latanoprost
Arm/Group Description	One drop self-administered in the study eye(s) once daily for 90 days		One drop self-administered in the study eye(s) once daily for 90 days
All Cause Mortality
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/353 (1.1%)		6/348 (1.7%)
Cardiac disorders
Cardiac arrest	1/353 (0.3%)		0/348 (0%)
Myocardial Infarction	1/353 (0.3%)		0/348 (0%)
Gastrointestinal disorders
Intestinal obstruction	1/353 (0.3%)		0/348 (0%)
General disorders
Adverse drug reaction	0/353 (0%)		1/348 (0.3%)
Oedema peripheral	0/353 (0%)		1/348 (0.3%)
Musculoskeletal and connective tissue disorders
Back pain	0/353 (0%)		1/348 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/353 (0%)		1/348 (0.3%)
Nervous system disorders
Cerebrovascular accident	0/353 (0%)		1/348 (0.3%)
Renal and urinary disorders
Urinary incontinence	0/353 (0%)		1/348 (0.3%)
Surgical and medical procedures
Mastectomy	0/353 (0%)		1/348 (0.3%)
Vascular disorders
Thrombophlebitis	1/353 (0.3%)		0/348 (0%)
Hypotension	0/353 (0%)		1/348 (0.3%)
Other (Not Including Serious) Adverse Events
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/353 (0%)		0/348 (0%)

Limitations/Caveats

The subjective nature of the OSDI may not be sensitive enough to detect the effects of preservatives on the corneal surface. The measurement and quantification of OSD remains a considerable clinical challenge. (Pflugfelder and Baudoin, 2011)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Alcon reserves the right of prior review of any publication or presentation of information related to the study.