Trial Outcomes & Findings for Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues (NCT NCT00539526)
NCT ID: NCT00539526
Last Updated: 2019-04-24
Results Overview
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
COMPLETED
PHASE4
106 participants
Baseline, Month 3
2019-04-24
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.03%
bimatoprost 0.03%
|
Travoprost 0.004%
travoprost 0.004%
|
Latanoprost 0.005%
latanoprost 0.005%
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
38
|
|
Overall Study
COMPLETED
|
32
|
31
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.03%
n=35 Participants
bimatoprost 0.03%
|
Travoprost 0.004%
n=33 Participants
travoprost 0.004%
|
Latanoprost 0.005%
n=38 Participants
latanoprost 0.005%
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.3 years
n=5 Participants
|
65.4 years
n=7 Participants
|
67.3 years
n=5 Participants
|
67.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
Outcome measures
| Measure |
Bimatoprost 0.03%
n=35 Participants
bimatoprost 0.03%
|
Travoprost 0.004%
n=33 Participants
travoprost 0.004%
|
Latanoprost 0.005%
n=38 Participants
latanoprost 0.005%
|
|---|---|---|---|
|
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Baseline
|
0.74 Scores on Scale
Standard Error 0.10
|
0.86 Scores on Scale
Standard Error 0.12
|
0.74 Scores on Scale
Standard Error 0.11
|
|
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Month 3
|
0.05 Scores on Scale
Standard Error 0.1
|
0.07 Scores on Scale
Standard Error 0.13
|
0.06 Scores on Scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Month 3Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.
Outcome measures
| Measure |
Bimatoprost 0.03%
n=35 Participants
bimatoprost 0.03%
|
Travoprost 0.004%
n=33 Participants
travoprost 0.004%
|
Latanoprost 0.005%
n=38 Participants
latanoprost 0.005%
|
|---|---|---|---|
|
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Baseline
|
0.59 Scores on a Scale
Standard Error 0.12
|
0.48 Scores on a Scale
Standard Error 0.11
|
0.70 Scores on a Scale
Standard Error 0.13
|
|
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Month 3
|
0.15 Scores on a Scale
Standard Error 0.15
|
-0.07 Scores on a Scale
Standard Error 0.12
|
-0.18 Scores on a Scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Month 3Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Outcome measures
| Measure |
Bimatoprost 0.03%
n=35 Participants
bimatoprost 0.03%
|
Travoprost 0.004%
n=33 Participants
travoprost 0.004%
|
Latanoprost 0.005%
n=38 Participants
latanoprost 0.005%
|
|---|---|---|---|
|
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Baseline
|
9.1 Seconds
Standard Error 1.0
|
7.9 Seconds
Standard Error 0.8
|
8.6 Seconds
Standard Error 0.8
|
|
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Month 3
|
0.5 Seconds
Standard Error 0.9
|
1.7 Seconds
Standard Error 0.8
|
0.4 Seconds
Standard Error 1.0
|
Adverse Events
Bimatoprost 0.03%
Travoprost 0.004%
Latanoprost 0.005%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimatoprost 0.03%
n=35 participants at risk
bimatoprost 0.03%
|
Travoprost 0.004%
n=33 participants at risk
travoprost 0.004%
|
Latanoprost 0.005%
n=38 participants at risk
latanoprost 0.005%
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.9%
1/35
|
6.1%
2/33
|
0.00%
0/38
|
Additional Information
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