Trial Outcomes & Findings for An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® (NCT NCT01664039)

Last Updated: 2015-08-03

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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 analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

104 participants

Primary outcome timeframe

Baseline (Day 0), Month 6

Results posted on

2015-08-03

Participant Flow

Subjects were recruited from 2 study centers located in Slovenia.

All enrolled subjects were randomized. This reporting group includes all randomized subjects (104). Note: 1 subject randomized to Travatan and 3 subjects randomized to Lumigan did not receive treatment.

Participant milestones

Participant milestones
Measure	TRAVATAN One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN One drop to the study eye(s) once a day in the evening, for 6 months
Overall Study STARTED	52	52
Overall Study COMPLETED	46	43
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	TRAVATAN One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN One drop to the study eye(s) once a day in the evening, for 6 months
Overall Study Adverse Event	3	4
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	3
Overall Study Noncompliance	1	1

Baseline Characteristics

An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRAVATAN n=52 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=52 Participants One drop to the study eye(s) once a day in the evening for 6 months	Total n=104 Participants Total of all reporting groups
Age, Customized Under 60 years	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants
Age, Customized 60 or more years	27 participants n=5 Participants	26 participants n=7 Participants	53 participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	16 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	36 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Month 6

Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 Baseline (Day 0)	24.66 mmHg Standard Deviation 3.65	24.59 mmHg Standard Deviation 4.14
Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 Change from Baseline at Month 6, n=46,43	-7.61 mmHg Standard Deviation 4.32	-7.35 mmHg Standard Deviation 3.84

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 6, Month 3

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. 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 analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Mean Change From Baseline in IOP at Week 6 and Month 3 Change from Baseline at Week 6, n=46,46	-7.50 mmHg Standard Deviation 3.80	-7.02 mmHg Standard Deviation 3.28
Mean Change From Baseline in IOP at Week 6 and Month 3 Change from Baseline at Month 3, n=46,44	-7.96 mmHg Standard Deviation 3.71	-7.82 mmHg Standard Deviation 3.15

SECONDARY outcome

Timeframe: Week 6, Month 3, Month 6

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Percentage of Subjects Who Reached Target IOP at Each Visit Week 6, n=46,46	69.6 percentage of participants	56.5 percentage of participants
Percentage of Subjects Who Reached Target IOP at Each Visit Month 3, n=46,44	71.7 percentage of participants	70.5 percentage of participants
Percentage of Subjects Who Reached Target IOP at Each Visit Month 6, n=46,43	73.9 percentage of participants	67.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 6, Month 3, Month 6

Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.

Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +1 Grade Change from Baseline at Week 6	23 participants	20 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit Baseline, Grade 0	40 participants	31 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit Baseline, Grade 1	9 participants	17 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit Baseline, Grade 2	1 participants	1 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit -1 Grade Change from Baseline at Week 6	2 participants	1 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit 0 Grade Change from Baseline at Week 6	20 participants	23 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +2 Grade Change from Baseline at Week 6	1 participants	2 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit -1 Grade Change from Baseline at Month 3	2 participants	1 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit 0 Grade Change from Baseline at Month 3	13 participants	15 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +1 Grade Change from Baseline at Month 3	25 participants	26 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +2 Grade Change from Baseline at Month 3	6 participants	2 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit -1 Grade Change from Baseline at Month 6	0 participants	1 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit 0 Grade Change from Baseline at Month 6	20 participants	15 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +1 Grade Change from Baseline at Month 6	23 participants	25 participants
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit +2 Grade Change from Baseline at Month 6	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Month 3, Month 6

Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.

Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 Baseline, Grade 0	41 participants	39 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 Baseline, Grade 1	8 participants	9 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 Baseline, Grade 2	1 participants	1 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 -1 Grade Change from Baseline at Month 3	7 participants	4 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 0 Grade Change from Baseline at Month 3	33 participants	33 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 +1 Grade Change from Baseline at Month 3	6 participants	7 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 -1 Grade Change from Baseline at Month 6	4 participants	7 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 0 Grade Change from Baseline at Month 6	28 participants	25 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 +1 Grade Change from Baseline at Month 6	13 participants	10 participants
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 +2 Grade Change from Baseline at Month 6	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Month 3, Month 6

Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.

Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Baseline, Grade 0	44 participants	39 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Baseline, Grade 1	6 participants	9 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Baseline, Grade 2	0 participants	1 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 3, -1 Grade Change from Baseline	6 participants	6 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 3, 0 Grade Change from Baseline	36 participants	33 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 3, +1 Grade Change from Baseline	3 participants	5 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 3, +2 Grade Change from Baseline	1 participants	0 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 6, -1 Grade Change from Baseline	4 participants	7 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 6, 0 Grade Change from Baseline	31 participants	26 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 6, +1 Grade Change from Baseline	11 participants	9 participants
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 Month 6, +2 Grade Change from Baseline	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Month 3, Month 6

Population: This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively.

The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.

Outcome measures

Outcome measures
Measure	TRAVATAN n=48 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=48 Participants One drop to the study eye(s) once a day in the evening for 6 months
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 Baseline (Day 0)	14.6 units on a scale Standard Deviation 14.8	10.6 units on a scale Standard Deviation 10.5
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 Change from Baseline at Month 3, n=44,43	-0.3 units on a scale Standard Deviation 12.2	0.0 units on a scale Standard Deviation 10.4
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 Change from Baseline at Month 6, n=44,42	0.4 units on a scale Standard Deviation 16.2	1.7 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline (Day 0), Month 3, Month 6

TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN n=50 Participants One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 Participants One drop to the study eye(s) once a day in the evening for 6 months
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 Baseline (Day 0)	10.7 seconds Standard Deviation 2.7	11.7 seconds Standard Deviation 3.2
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 Change from Baseline at Month 3, n=46,44	-1.6 seconds Standard Deviation 5.3	-1.8 seconds Standard Deviation 4.0
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 Change from Baseline at Month 6, n=46,43	-2.2 seconds Standard Deviation 3.6	-2.2 seconds Standard Deviation 5.1

Adverse Events

TRAVATAN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LUMIGAN

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TRAVATAN n=51 participants at risk One drop to the study eye(s) once a day in the evening for 6 months	LUMIGAN n=49 participants at risk One drop to the study eye(s) once a day in the evening for 6 months
Surgical and medical procedures Thromboendarterectomy	0.00% 0/51 • Adverse events (AEs) were collected for the duration of the study (Sep 2012 - Jun 2014). This analysis population includes all subjects who received at least 1 dose of either study treatment. An AE was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as both volunteered and elicited comments from the study subjects.	2.0% 1/49 • Adverse events (AEs) were collected for the duration of the study (Sep 2012 - Jun 2014). This analysis population includes all subjects who received at least 1 dose of either study treatment. An AE was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as both volunteered and elicited comments from the study subjects.

Other adverse events

Adverse event data not reported

Additional Information

Global Brand Lead, Medical Affairs, Glaucoma

Alcon Research, Ltd

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor 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