Trial Outcomes & Findings for Travoprost 3-Month Safety and Efficacy Study (NCT NCT01453855)

Last Updated: 2013-10-18

Results Overview

As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1099 participants

Primary outcome timeframe

Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

Results posted on

2013-10-18

Participant Flow

Subjects were recruited from 60 investigational centers, including 52 in the US, 2 each in Sweden, Germany, and Austria, and 1 each in Spain and Finland.

Of the 1099 enrolled, 235 did not meet inclusion/exclusion criteria and were exited from the study prior to randomization. This reporting group includes all randomized subjects (864).

Participant milestones

Participant milestones
Measure	Travoprost 0.003% Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Overall Study STARTED	442	422
Overall Study COMPLETED	432	408
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Travoprost 0.003% Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Overall Study Adverse Event	3	4
Overall Study Lost to Follow-up	2	1
Overall Study Patient Decision Unrel to Adverse Event	3	3
Overall Study Noncompliance	1	0
Overall Study Inadequate Control of IOP	1	5
Overall Study Other	0	1

Baseline Characteristics

Travoprost 3-Month Safety and Efficacy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost 0.003% n=442 Participants Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN n=421 Participants Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months	Total n=863 Participants Total of all reporting groups
Age, Customized 18 to 64 years	189 Participants n=93 Participants	193 Participants n=4 Participants	382 Participants n=27 Participants
Age, Customized ≥ 65 years	253 Participants n=93 Participants	228 Participants n=4 Participants	481 Participants n=27 Participants
Sex: Female, Male Female	269 Participants n=93 Participants	246 Participants n=4 Participants	515 Participants n=27 Participants
Sex: Female, Male Male	173 Participants n=93 Participants	175 Participants n=4 Participants	348 Participants n=27 Participants

PRIMARY outcome

Timeframe: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

Population: The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.

Outcome measures

Outcome measures
Measure	Travoprost 0.003% n=442 Participants Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN n=416 Participants Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 2 at 8 AM	19.4 millimeters mercury (mmHg) Standard Error 0.16	19.5 millimeters mercury (mmHg) Standard Error 0.17
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 2 at 10 AM	18.6 millimeters mercury (mmHg) Standard Error 0.16	18.6 millimeters mercury (mmHg) Standard Error 0.16
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 2 at 4 PM	18.0 millimeters mercury (mmHg) Standard Error 0.16	18.3 millimeters mercury (mmHg) Standard Error 0.16
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 6 at 8 AM	19.3 millimeters mercury (mmHg) Standard Error 0.16	19.3 millimeters mercury (mmHg) Standard Error 0.17
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 6 at 10 AM	18.5 millimeters mercury (mmHg) Standard Error 0.16	18.6 millimeters mercury (mmHg) Standard Error 0.17
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Week 6 at 4 PM	18.0 millimeters mercury (mmHg) Standard Error 0.16	18.1 millimeters mercury (mmHg) Standard Error 0.17
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Month 3 at 8 AM	19.2 millimeters mercury (mmHg) Standard Error 0.17	19.3 millimeters mercury (mmHg) Standard Error 0.18
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Month 3 at 10 AM	18.3 millimeters mercury (mmHg) Standard Error 0.17	18.6 millimeters mercury (mmHg) Standard Error 0.18
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) Month 3 at 4 PM	18.0 millimeters mercury (mmHg) Standard Error 0.16	18.0 millimeters mercury (mmHg) Standard Error 0.17

Adverse Events

Travoprost 0.003%

Serious events: 5 serious events

Other events: 56 other events

Deaths: 0 deaths

TRAVATAN

Serious events: 7 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Travoprost 0.003% n=442 participants at risk Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN n=421 participants at risk Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Gastrointestinal disorders Abdominal pain	0.23% 1/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
General disorders Chest Pain	0.45% 2/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Injury, poisoning and procedural complications Collapse of lung	0.23% 1/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Infections and infestations Gastroenteritis	0.23% 1/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Injury, poisoning and procedural complications Injury	0.23% 1/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 1/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.00% 0/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Infections and infestations Cellulitis	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Number of events 2 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Immune system disorders Drug hypersensitivity	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Infections and infestations Erysipelas	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Cardiac disorders Myocardial infarction	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	0.24% 1/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.

Other adverse events

Other adverse events
Measure	Travoprost 0.003% n=442 participants at risk Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months	TRAVATAN n=421 participants at risk Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Eye disorders Ocular hyperaemia	7.0% 31/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	8.1% 34/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.
Eye disorders Conjunctival hyperaemia	5.7% 25/442 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.	7.1% 30/421 • Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication. This reporting group includes subjects exposed to the study medication.

Additional Information

Theresa A Landry, PhD

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