Trial Outcomes & Findings for Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01253902)
NCT ID: NCT01253902
Last Updated: 2012-11-07
Results Overview
Conjunctival hyperemia was analyzed using the average of the scores of both eyes. 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 on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).
COMPLETED
PHASE4
164 participants
Week 12
2012-11-07
Participant Flow
Participant milestones
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
55
|
|
Overall Study
COMPLETED
|
51
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
n=56 Participants
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
n=53 Participants
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
n=55 Participants
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
65.1 Years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
64.7 Years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
64.3 Years
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-treat population (ITT) included all participants who were randomized to study medication.
Conjunctival hyperemia was analyzed using the average of the scores of both eyes. 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 on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
n=56 Participants
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
n=53 Participants
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
n=55 Participants
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
|---|---|---|---|
|
Mean Conjunctival Hyperemia at Week 12
|
0.42 Score on a scale
Standard Deviation 0.48
|
0.46 Score on a scale
Standard Deviation 0.44
|
0.44 Score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat (ITT) population included all participants who were randomized and received study medication.
Corneal staining was analyzed using the average of the scores of both eyes. 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=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (\>20 puncta) and 3=Severe (too many puncta to count).
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
n=56 Participants
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
n=53 Participants
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
n=55 Participants
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
|---|---|---|---|
|
Mean Corneal Staining With Fluorescein at Week 12
|
0.31 Score on a scale
Standard Deviation 0.45
|
0.32 Score on a scale
Standard Deviation 0.48
|
0.22 Score on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat (ITT) population included all participants who were randomized and received study medication.
Tear Break Up Time was analyzed using the average of the readings of both eyes. 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.
Outcome measures
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
n=56 Participants
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
n=53 Participants
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
n=55 Participants
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
|---|---|---|---|
|
Mean Tear Break Up Time (TBUT) at Week 12
|
9.7 Seconds
Standard Deviation 5.71
|
9.7 Seconds
Standard Deviation 4.96
|
9.3 Seconds
Standard Deviation 4.04
|
Adverse Events
Bimatoprost Ophthalmic Solution 0.01%
Travoprost Ophthalmic Solution 0.004%
Latanoprost Ophthalmic Solution 0.005%
Serious adverse events
| Measure |
Bimatoprost Ophthalmic Solution 0.01%
n=56 participants at risk
One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Travoprost Ophthalmic Solution 0.004%
n=53 participants at risk
One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
Latanoprost Ophthalmic Solution 0.005%
n=55 participants at risk
One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia resulting in death
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
|
Gastrointestinal disorders
Punctured colon
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
|
Infections and infestations
Infection from Punctured colon
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
|
Eye disorders
Branch retinal artery occlusion
|
1.8%
1/56
|
0.00%
0/53
|
0.00%
0/55
|
|
Vascular disorders
Transient Ischemic Attack
|
0.00%
0/56
|
0.00%
0/53
|
1.8%
1/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/56
|
1.9%
1/53
|
0.00%
0/55
|
Other adverse events
Adverse event data not reported
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