Trial Outcomes & Findings for Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT00690794)

Last Updated: 2012-07-24

Results Overview

The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point 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. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

726 participants

Primary outcome timeframe

Baseline, Day 90

Results posted on

2012-07-24

Participant Flow

Patients were recruited from 70 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.

726 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy study visit (intent-to-treat): 678.

Participant milestones

Participant milestones
Measure	Travoprost One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost One drop self-administered in the study eye(s) once daily for 90 days
Overall Study STARTED	363	363
Overall Study COMPLETED	342	328
Overall Study NOT COMPLETED	21	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Travoprost One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost One drop self-administered in the study eye(s) once daily for 90 days
Overall Study Adverse Event	12	10
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	0	9
Overall Study Protocol Violation	6	7
Overall Study Noncompliance	1	2
Overall Study Other not specified	1	3

Baseline Characteristics

Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost n=343 Participants One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost n=335 Participants One drop self-administered in the study eye(s) once daily for 90 days	Total n=678 Participants Total of all reporting groups
Age Continuous	67.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	67.8 years STANDARD_DEVIATION 10.8 • n=7 Participants	67.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants	230 Participants n=7 Participants	441 Participants n=5 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	105 Participants n=7 Participants	237 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 90

Population: 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. An Observed Case analysis (OC) was performed for the ITT population.

Outcome measures

Outcome measures
Measure	Travoprost n=339 Participants One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost n=328 Participants One drop self-administered in the study eye(s) once daily for 90 days
Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score	-11.3 Units on a scale Standard Error 0.9	-11.4 Units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: 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 the total number of patients analyzed.

Outcome measures

Outcome measures
Measure	Travoprost n=342 Participants One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost n=330 Participants One drop self-administered in the study eye(s) once daily for 90 days
Percentage of Patients With Corneal Fluorescein Staining Score = 0	37.1 percentage of patients	40.0 percentage of patients

Adverse Events

Travoprost

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Latanoprost

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER

Measure	Travoprost n=363 participants at risk One drop self-administered in the study eye(s) once daily for 90 days	Latanoprost n=363 participants at risk One drop self-administered in the study eye(s) once daily for 90 days
Cardiac disorders Coronary Artery Occlusion	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Metabolism and nutrition disorders Hyponatraemia	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Nervous system disorders Convulsion	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Cardiac disorders Atrial Fibrillation	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Cardiac disorders Brachycardia	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Cardiac disorders Coronary Artery Disease	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Gastrointestinal disorders Abdominal Pain	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.55% 2/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
General disorders Chest Pain	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Infections and infestations Diverticulitis	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.
Nervous system disorders Cerebrovascular accident	0.00% 0/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.	0.28% 1/363 • Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009. This reporting group includes all patients who received the test article.