A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00471380
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: travoprost 0.004% and brinzolamide 1%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Crossover group ABB 3 period, 2 treatment cross-over model: 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)	Drug: travoprost 0.004% and brinzolamide 1%; Group A = 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.); Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle; group B = 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.).
Active Comparator: Crossover group BAA 3 period, 2 treatment cross-over model: 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).	Drug: travoprost 0.004% and brinzolamide 1%; Group A = 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.); Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle; group B = 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.).

Outcome Measures

Primary Outcome Measures

1. Intra Ocular Pressure (IOP) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent

• Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension

• Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM

• Stable visual field in last 6 months

• 6 weeks wash out from previous topical medications

Exclusion Criteria:

• Age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catania	Catania		Italy	95123

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Marcello Fornoni, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00471380
• Other Study ID Numbers: IT-04-04; EudraCT 200600362737
• First Posted: May 9, 2007
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Travoprost; Dorzolamide; Brinzolamide

Study Results

Participant Flow

Recruitment Details	46 patients suffering from POAG or ocular hypertension, with an intraocular pressure that was insufficiently controlled were recruited.
Pre-assignment Detail	Subjects meeting the inclusion/exclusion criteria were enrolled.

Arm/Group Title	Crossover Group ABB	Crossover Group BAA
Arm/Group Description	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)	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).
Period Title: First Intervention
STARTED	22	24
COMPLETED	18	20
NOT COMPLETED	4	4
Period Title: First Intervention
STARTED	18	20
COMPLETED	18	16
NOT COMPLETED	0	4
Period Title: First Intervention
STARTED	18	16
COMPLETED	17	14
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Overall Study Population
Arm/Group Description
Overall Participants	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 50%
>=65 years	23 50%
Sex: Female, Male (Count of Participants)
Female	28 60.9%
Male	18 39.1%

Outcome Measures

1. Primary Outcome

Title	Intra Ocular Pressure (IOP)
Description	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
Time Frame	Baseline, end of each period (week 8, week 16, week 24)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crossover Group ABB	Crossover Group BAA
Arm/Group Description	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)	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).
Measure Participants	22	24
Week 8	179.20 (25.42)	191.89 (52.59)
Week 16	188.82 (32.05)	196.26 (59.07)
Week 24	201.50 (41.01)	191.93 (41.39)

Adverse Events

Time Frame	6 Months
Arm/Group Title	Treatment A		Treatment B
Arm/Group Description	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.).		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.).
All Cause Mortality
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		2/24 (8.3%)
Injury, poisoning and procedural complications
Sternal Fracture	0/22 (0%)	0	1/24 (4.2%)	1
Traumatic Brain Injury	0/22 (0%)	0	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/22 (50%)		3/24 (12.5%)
Eye disorders
Conjunctivitis Allergic	3/22 (13.6%)	3	1/24 (4.2%)	1
Eye Irritation	8/22 (36.4%)	8	2/24 (8.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.