Trial Outcomes & Findings for Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN (NCT NCT00798759)

Results Overview

Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

236 participants

Primary outcome timeframe

Day 0, Day 84

Results posted on

2012-06-01

Participant Flow

Patients were recruited from 22 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for six months prior to Visit 1 were enrolled.

236 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and completed the study (intent-to-treat): 215.

Participant milestones

Participant milestones
Measure	Travoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks	Latanoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks
Overall Study STARTED	117	119
Overall Study COMPLETED	109	106
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Travoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks	Latanoprost One drop self-administered in the study eye(s) once daily at night for 12 weeks
Overall Study Adverse Event	3	3
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	4	8
Overall Study Other	0	1

Baseline Characteristics

Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost n=109 Participants One drop self-administered in the study eye(s) once daily at night for 12 weeks	Latanoprost n=106 Participants One drop self-administered in the study eye(s) once daily at night for 12 weeks	Total n=215 Participants Total of all reporting groups
Age Continuous	66.3 years STANDARD_DEVIATION 12.1 • n=5 Participants	69.0 years STANDARD_DEVIATION 10.4 • n=7 Participants	67.6 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	71 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	35 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0, Day 84

Population: Intent-to-Treat: All patients who received test article and completed the trial.

Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.

Outcome measures

Outcome measures
Measure	Travoprost n=109 Participants One drop self administered in the study eye(s) once daily at night for 12 weeks	Latanoprost n=105 Participants One drop self administered in the study eye(s) once daily at night for 12 weeks
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)	0.7 Seconds Standard Error 0.1	0.6 Seconds Standard Error 0.2

SECONDARY outcome

Timeframe: Day 0, Day 84

Population: Intent-to-Treat: All patients who received test article and completed the trial.

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. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.

Outcome measures

Outcome measures
Measure	Travoprost n=108 Participants One drop self administered in the study eye(s) once daily at night for 12 weeks	Latanoprost n=106 Participants One drop self administered in the study eye(s) once daily at night for 12 weeks
Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score	-1.9 Units on a scale Standard Error 1.2	0.6 Units on a scale Standard Error 1.5

Adverse Events

Travoprost

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Latanoprost

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Travoprost n=117 participants at risk One drop self administered in the study eye(s) once daily at night for 12 weeks	Latanoprost n=119 participants at risk One drop self administered in the study eye(s) once daily at night for 12 weeks
Investigations Blood urine present	0.85% 1/117 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.	0.00% 0/119 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.
Metabolism and nutrition disorders Dehydration	0.00% 0/117 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.	0.84% 1/119 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.
Surgical and medical procedures Coronary Arterial Stent Insertion	0.00% 0/117 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.	0.84% 1/119 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.

Other adverse events

Other adverse events
Measure	Travoprost n=117 participants at risk One drop self administered in the study eye(s) once daily at night for 12 weeks	Latanoprost n=119 participants at risk One drop self administered in the study eye(s) once daily at night for 12 weeks
Eye disorders Dry Eye	6.0% 7/117 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.	2.5% 3/119 • Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009. This reporting group includes all patients who received test article.

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