Trial Outcomes & Findings for Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure (NCT NCT02003391)

NCT ID: NCT02003391

Last Updated: 2016-08-08

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

157 participants

Primary outcome timeframe

Week 4

Results posted on

2016-08-08

Participant Flow

Participants were recruited from 14 investigational centers located in Latin America, Australia, Russia, and Korea.

Of the 157 participants enrolled, 1 participant was exited as a screen failure. This reporting group includes all randomized participants (156).

Participant milestones

Participant milestones
Measure	DuoTrav Travoprost/timolol for 8 weeks	Beta-blocker 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
Overall Study STARTED	81	75
Overall Study Safety Population	81	75
Overall Study Intent to Treat Population	78	73
Overall Study COMPLETED	78	73
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DuoTrav Travoprost/timolol for 8 weeks	Beta-blocker 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
Overall Study Withdrawal by Subject	2	1
Overall Study Protocol Violation	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DuoTrav n=78 Participants Travoprost/timolol for 8 weeks	Beta-blocker n=73 Participants 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol	Total n=151 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 12.76 • n=5 Participants	63.8 years STANDARD_DEVIATION 13.29 • n=7 Participants	63.3 years STANDARD_DEVIATION 12.98 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intent to treat with a measurement in the study eye at Week 4

Outcome measures

Outcome measures
Measure	DuoTrav n=78 Participants Travoprost/timolol for 4 weeks	Beta-blocker n=72 Participants Beta-blocker monotherapy for 4 weeks
Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye	16.6129 mmHg Interval to 17.1451 NA = not quantifiable (calculated to infinity)	21.2320 mmHg Interval to 21.7858 NA = not quantifiable (calculated to infinity)

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 4

Population: Intent to treat with a measurement in the study eye at Week 4

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	DuoTrav n=78 Participants Travoprost/timolol for 4 weeks	Beta-blocker n=72 Participants Beta-blocker monotherapy for 4 weeks
Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	-5.840 mmHg Standard Deviation 3.4870	-1.069 mmHg Standard Deviation 2.4969

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 4

Population: Intent to treat with a measurement in the study eye at Week 4

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	DuoTrav n=78 Participants Travoprost/timolol for 4 weeks	Beta-blocker n=72 Participants Beta-blocker monotherapy for 4 weeks
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye	-25.365 Percent Change Standard Deviation 14.2093	-4.716 Percent Change Standard Deviation 11.4005

Adverse Events

DuoTrav

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Beta-blocker

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Global Brand Leader, 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

Other adverse events
Measure	DuoTrav n=81 participants at risk Travoprost/timolol for 8 weeks	Beta-blocker n=75 participants at risk 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
Eye disorders Blepharal pigmentation	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Cataract	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Conjunctivitis allergic	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Dry eye	2.5% 2/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	2.7% 2/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Eye irritation	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Eye pain	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Eye pruritus	4.9% 4/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Eyelids pruritus	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Ocular hyperaemia	6.2% 5/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Ocular surface disease	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Immune system disorders Hypersensitivity	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Acute tonsillitis	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Bronchitis	0.00% 0/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Influenza	0.00% 0/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	2.7% 2/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Nasopharyngitis	2.5% 2/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	2.7% 2/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Pharyngitis	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Musculoskeletal and connective tissue disorders Arthritis	1.2% 1/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/81 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	1.3% 1/75 • Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.