Trial Outcomes & Findings for Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects (NCT NCT00735449)

Results Overview

Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

204 participants

Primary outcome timeframe

Week 12

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Combigan® Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Overall Study STARTED	102	102
Overall Study COMPLETED	95	96
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combigan® n=102 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=102 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)	Total n=204 Participants Total of all reporting groups
Age, Continuous	64.5 years n=5 Participants	65.9 years n=7 Participants	65.4 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	45 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	57 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.

Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Outcome measures

Outcome measures
Measure	Combigan® n=94 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=94 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Mean Intraocular Pressure (IOP) at 10 AM at Week 12	15.1 Millimeters of mercury (mmHg) Standard Deviation 2.59	16.9 Millimeters of mercury (mmHg) Standard Deviation 2.46

SECONDARY outcome

Timeframe: Week 6

Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.

Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Outcome measures
Measure	Combigan® n=98 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=97 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Mean Intraocular Pressure (IOP) at 10 AM at Week 6	15.9 Millimeters of mercury (mmHg) Standard Deviation 3.10	16.7 Millimeters of mercury (mmHg) Standard Deviation 2.78

SECONDARY outcome

Timeframe: Week 12

Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.

Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Outcome measures
Measure	Combigan® n=96 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=94 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Mean Intraocular Pressure (IOP) at 8 AM at Week 12	17.0 Millimeters of mercury (mmHg) Standard Deviation 2.55	17.7 Millimeters of mercury (mmHg) Standard Deviation 2.58

SECONDARY outcome

Timeframe: Week 6

Population: Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.

Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Outcome measures
Measure	Combigan® n=98 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=97 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Mean Intraocular Pressure (IOP) at 8 AM at Week 6	17.3 Millimeters of mercury (mmHg) Standard Deviation 2.87	17.8 Millimeters of mercury (mmHg) Standard Deviation 3.17

SECONDARY outcome

Timeframe: Week 12

Population: Safety population, which included all patients who started the study (randomized) and were treated.

Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).

Outcome measures

Outcome measures
Measure	Combigan® n=102 Participants Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=102 Participants Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Number of Subjects With Adverse Events	15 Participants	13 Participants

Adverse Events

Combigan®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Timolol Maleate 0.5%

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combigan® n=102 participants at risk Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol Maleate 0.5% n=102 participants at risk Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Respiratory, thoracic and mediastinal disorders Acute exacerbation of COPD	0.00% 0/102	0.98% 1/102
Infections and infestations Bacterial bronchitis	0.00% 0/102	0.98% 1/102

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER