Trial Outcomes & Findings for A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension (NCT NCT00471380)
NCT ID: NCT00471380
Last Updated: 2010-03-16
Results Overview
Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Baseline, end of each period (week 8, week 16, week 24)
Results posted on
2010-03-16
Participant Flow
46 patients suffering from POAG or ocular hypertension, with an intraocular pressure that was insufficiently controlled were recruited.
Subjects meeting the inclusion/exclusion criteria were enrolled.
Participant milestones
| Measure |
Crossover Group ABB
Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
|
Crossover Group BAA
Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
|
|---|---|---|
|
First Intervention
STARTED
|
22
|
24
|
|
First Intervention
COMPLETED
|
18
|
20
|
|
First Intervention
NOT COMPLETED
|
4
|
4
|
|
Second Intervention
STARTED
|
18
|
20
|
|
Second Intervention
COMPLETED
|
18
|
16
|
|
Second Intervention
NOT COMPLETED
|
0
|
4
|
|
Third Intervention
STARTED
|
18
|
16
|
|
Third Intervention
COMPLETED
|
17
|
14
|
|
Third Intervention
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=46 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of each period (week 8, week 16, week 24)Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points
Outcome measures
| Measure |
Crossover Group ABB
n=22 Participants
Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
|
Crossover Group BAA
n=24 Participants
Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
|
|---|---|---|
|
Intra Ocular Pressure (IOP)
Week 8
|
179.20 mm Hg (millimeters mercury)*week
Standard Deviation 25.42
|
191.89 mm Hg (millimeters mercury)*week
Standard Deviation 52.59
|
|
Intra Ocular Pressure (IOP)
Week 16
|
188.82 mm Hg (millimeters mercury)*week
Standard Deviation 32.05
|
196.26 mm Hg (millimeters mercury)*week
Standard Deviation 59.07
|
|
Intra Ocular Pressure (IOP)
Week 24
|
201.50 mm Hg (millimeters mercury)*week
Standard Deviation 41.01
|
191.93 mm Hg (millimeters mercury)*week
Standard Deviation 41.39
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment B
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A
n=22 participants at risk
Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
|
Treatment B
n=24 participants at risk
Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/22 • 6 Months
|
4.2%
1/24 • Number of events 1 • 6 Months
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/22 • 6 Months
|
4.2%
1/24 • Number of events 1 • 6 Months
|
Other adverse events
| Measure |
Treatment A
n=22 participants at risk
Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
|
Treatment B
n=24 participants at risk
Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
|
|---|---|---|
|
Eye disorders
Conjunctivitis Allergic
|
13.6%
3/22 • Number of events 3 • 6 Months
|
4.2%
1/24 • Number of events 1 • 6 Months
|
|
Eye disorders
Eye Irritation
|
36.4%
8/22 • Number of events 8 • 6 Months
|
8.3%
2/24 • Number of events 2 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any formal presentation of data publication from this study has to be a joint presentation from both the Investigators and the Sponsor. Being the study multicentric, it is mandatory that the first publication is based on data from all the centres, analysed according to the protocol. Data from a single Centre can not be presented, unless there Is a formal agreement from the other Investigators and Alcon.
- Publication restrictions are in place
Restriction type: OTHER