Trial Outcomes & Findings for Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT00804648)
NCT ID: NCT00804648
Last Updated: 2015-03-06
Results Overview
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
following 3 days of treatment
Results posted on
2015-03-06
Participant Flow
Participant milestones
| Measure |
Hemihydrate/Maleate/Maleate Gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
|
Maleate/Maleate Gel/Hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
|
Maleate Gel/Hemihydrate/Maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
|
Hemihydrate/Maleate Gel/Maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
|
Maleate/Hemihydrate/Maleate Gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
|
Maleate Gel/Maleate/Hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
First Intervention
COMPLETED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
Second Intervention
COMPLETED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Invervention
STARTED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
Third Invervention
COMPLETED
|
3
|
5
|
6
|
4
|
4
|
8
|
|
Third Invervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Overall
n=30 Participants
|
|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: following 3 days of treatmentAssessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Stinging on Instillation
|
0.6 Units on a scale
Standard Deviation 1.0
|
1.0 Units on a scale
Standard Deviation 1.4
|
0.6 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Conjunctival Hyperemia
|
0.2 Units on a scale
Standard Deviation 0.5
|
0.4 Units on a scale
Standard Deviation 0.5
|
0.3 Units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: following 3 days of treatmentOutcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Tear Film Break-up Time
|
8.5 Seconds
Standard Deviation 6.1
|
7.7 Seconds
Standard Deviation 4.9
|
8.5 Seconds
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Corneal Staining Grade
|
1.2 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 0.9
|
1.0 Units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by the investigator using a slit lamp, counting the number of spots.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Corneal Staining Count
|
10.5 Number of spots
Standard Deviation 12.5
|
10.4 Number of spots
Standard Deviation 13.4
|
8.3 Number of spots
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: following 3 days of treatmentOutcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Intraoclular Pressure
|
16.3 mm of mercury
Standard Deviation 3.1
|
16.2 mm of mercury
Standard Deviation 2.4
|
16.2 mm of mercury
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: following 3 days of treatmentSchirmer's measures basic tear function. The higher the number, the less dry the eye.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Basic Schirmer's
|
17.7 mm of moisture
Standard Deviation 9.7
|
14.8 mm of moisture
Standard Deviation 7.3
|
15.4 mm of moisture
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Conjunctival Staining - Nasal Grade
|
1.2 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 1.0
|
1.3 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by investigator using slit lamp and counting number of spots.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Conjunctival Staining - Nasal Count
|
11.0 number of spots
Standard Deviation 12.5
|
10.3 number of spots
Standard Deviation 15.7
|
12.9 number of spots
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Conjunctival Staining - Temporal Grade
|
0.8 Units on a scale
Standard Deviation 0.6
|
0.7 Units on a scale
Standard Deviation 0.7
|
0.8 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: following 3 days of treatmentAssessed by investigator using a slit lamp and counting number of spots.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Conjunctival Staining - Temporal Count
|
4.7 number of spots
Standard Deviation 7.3
|
4.8 number of spots
Standard Deviation 8.6
|
5.3 number of spots
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: following 3 days of treatmentThe visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.
Outcome measures
| Measure |
Timolol Hemihydrate 0.5%
n=30 Participants
|
Timolol Maleate 0.5%
n=30 Participants
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 Participants
|
|---|---|---|---|
|
Visual Acuity
|
52.3 number of letters
Standard Deviation 5.6
|
52.5 number of letters
Standard Deviation 6.1
|
51.4 number of letters
Standard Deviation 5.8
|
Adverse Events
Timolol Hemihydrate 0.5%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Timolol Maleate 0.5%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Timolol Maleate Gel Forming Solution 0.5%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Timolol Hemihydrate 0.5%
n=30 participants at risk
|
Timolol Maleate 0.5%
n=30 participants at risk
|
Timolol Maleate Gel Forming Solution 0.5%
n=30 participants at risk
|
|---|---|---|---|
|
Eye disorders
Tearing
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
0.00%
0/30
|
|
Eye disorders
Blurred Vision
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
Additional Information
Arthur Shedden MD
Vistakon
Phone: 904-443-1557
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submission for publication or presentation, the PI will provide the Sponsor with at least 60 days for review of a manuscript. If requested in writing, the PI will withhold publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER