Trial Outcomes & Findings for Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005% (NCT NCT00440011)
NCT ID: NCT00440011
Last Updated: 2019-04-25
Results Overview
Intraocular Pressure
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
266 participants
Primary outcome timeframe
Month 3
Results posted on
2019-04-25
Participant Flow
Participant milestones
| Measure |
Bimatoprost
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
135
|
|
Overall Study
COMPLETED
|
127
|
132
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Bimatoprost
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%
Baseline characteristics by cohort
| Measure |
Bimatoprost
n=131 Participants
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
n=135 Participants
travoprost 0.004% 1 drop nightly for 3 months
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
131 participants
n=5 Participants
|
135 participants
n=7 Participants
|
266 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Intraocular Pressure
Outcome measures
| Measure |
Bimatoprost
n=127 Participants
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
n=132 Participants
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Intraocular Pressure (IOP)
|
17 mm Hg
Standard Deviation 3.1
|
17.5 mm Hg
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Month 3Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)
Outcome measures
| Measure |
Bimatoprost
n=127 Participants
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
n=132 Participants
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Tolerability - Conjunctival Hyperemia
|
15 participants
|
22 participants
|
Adverse Events
Bimatoprost
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Travoprost
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost
n=131 participants at risk
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
n=133 participants at risk
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/131
|
0.00%
0/133
|
Other adverse events
| Measure |
Bimatoprost
n=131 participants at risk
bimatoprost 0.03% 1 drop nightly for 3 months
|
Travoprost
n=133 participants at risk
travoprost 0.004% 1 drop nightly for 3 months
|
|---|---|---|
|
Eye disorders
Ocular Hyperaemia
|
3.1%
4/131
|
0.75%
1/133
|
|
Eye disorders
Eye Pruritus
|
2.3%
3/131
|
0.75%
1/133
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.76%
1/131
|
1.5%
2/133
|
|
Eye disorders
Punctate keratitis
|
0.76%
1/131
|
1.5%
2/133
|
|
Eye disorders
Eye Irritation
|
1.5%
2/131
|
0.00%
0/133
|
|
Eye disorders
Growth of Eyelashes
|
1.5%
2/131
|
0.00%
0/133
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/131
|
1.5%
2/133
|
|
Eye disorders
Abnormal Sensation in Eye
|
0.76%
1/131
|
0.00%
0/133
|
|
Eye disorders
Eye Discharge
|
0.76%
1/131
|
0.00%
0/133
|
|
Eye disorders
Eyelid Margin Crusting
|
0.00%
0/131
|
0.75%
1/133
|
|
Eye disorders
Lenticular Opacities
|
0.00%
0/131
|
0.75%
1/133
|
|
General disorders
Instillation Site Pruritus
|
0.00%
0/131
|
0.75%
1/133
|
|
General disorders
Oedema Peripheral
|
0.00%
0/131
|
0.75%
1/133
|
|
General disorders
Pain
|
0.76%
1/131
|
0.00%
0/133
|
|
General disorders
Sensation of Foreign Body
|
0.00%
0/131
|
0.75%
1/133
|
|
Infections and infestations
Conjunctivitis Viral
|
0.00%
0/131
|
0.75%
1/133
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/131
|
0.75%
1/133
|
|
Infections and infestations
Sinusitis
|
0.76%
1/131
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.76%
1/131
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.76%
1/131
|
0.00%
0/133
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.76%
1/131
|
0.00%
0/133
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/131
|
0.75%
1/133
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/131
|
0.75%
1/133
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/131
|
0.75%
1/133
|
|
Immune system disorders
Hypersensitivity
|
0.76%
1/131
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.76%
1/131
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/131
|
0.00%
0/133
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/131
|
0.75%
1/133
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/131
|
0.75%
1/133
|
|
Cardiac disorders
Palpitations
|
0.00%
0/131
|
0.75%
1/133
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/131
|
0.75%
1/133
|
|
Injury, poisoning and procedural complications
Foreign Body in Eye
|
0.76%
1/131
|
0.00%
0/133
|
|
Nervous system disorders
Headache
|
0.76%
1/131
|
0.00%
0/133
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/131
|
0.75%
1/133
|
|
Eye disorders
Blepharitis
|
0.76%
1/131
|
0.75%
1/133
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60