Trial Outcomes & Findings for Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension (NCT NCT00763061)

Results Overview

Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

111 participants

Primary outcome timeframe

At Week 12 - At the 9 AM time point for the patient's worse eye.

Results posted on

2010-03-02

Participant Flow

111 patients were enrolled in this study at 4 hospitals

Eligibility patients were washed out for up to 4 weeks before randomization

Participant milestones

Participant milestones
Measure	Travoprost 0.004% Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% Timolol in each eye, twice daily at 9 AM \& 9 PM
Overall Study STARTED	54	57
Overall Study COMPLETED	49	44
Overall Study NOT COMPLETED	5	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost 0.004% n=54 Participants Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% n=57 Participants Timolol in each eye, twice daily at 9 AM \& 9 PM	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 12 - At the 9 AM time point for the patient's worse eye.

Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Outcome measures

Outcome measures
Measure	Travoprost 0.004% n=49 Participants Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% n=44 Participants Timolol in each eye, twice daily at 9 AM \& 9 PM
Mean Intraocular Pressure (IOP) at 9 AM	16.3 millimeters mercury (mmHg) Standard Deviation 4.27	18.1 millimeters mercury (mmHg) Standard Deviation 4.32

PRIMARY outcome

Timeframe: At the 4 PM time point for the patient's worse eye.

Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Outcome measures

Outcome measures
Measure	Travoprost 0.004% n=49 Participants Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% n=44 Participants Timolol in each eye, twice daily at 9 AM \& 9 PM
Week 12 - Mean IOP At 4 PM	15.7 mmHg Standard Deviation 3.16	17.9 mmHg Standard Deviation 4.02

SECONDARY outcome

Timeframe: Baseline to Week 12 - at 9 AM

Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Outcome measures

Outcome measures
Measure	Travoprost 0.004% n=49 Participants Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% n=44 Participants Timolol in each eye, twice daily at 9 AM \& 9 PM
Mean IOP Change From Baseline at 9 AM	-5.1 mmHg Standard Deviation 4.35	-4.4 mmHg Standard Deviation 4.35

SECONDARY outcome

Timeframe: Baseline to Week 12 - at 4 PM

Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Outcome measures

Outcome measures
Measure	Travoprost 0.004% n=49 Participants Travoprost at 9 AM + Placebo \& 9 PM	Timolol 0.5% n=44 Participants Timolol in each eye, twice daily at 9 AM \& 9 PM
Mean IOP Change at 4 PM	-5.3 mmHg Standard Deviation 3.69	-3.7 mmHg Standard Deviation 4.15

Adverse Events

Travoprost 0.004%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Timolol 0.5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place