Trial Outcomes & Findings for Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT02059278)
NCT ID: NCT02059278
Last Updated: 2018-08-22
Results Overview
Evaluation of intraocular pressure using Goldmann applanation tonometry. Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points. Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points
COMPLETED
PHASE3
335 participants
Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84
2018-08-22
Participant Flow
Participant milestones
| Measure |
T-2345
T-2345 Ophthalmic Solution
|
Xalatan
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
170
|
|
Overall Study
COMPLETED
|
162
|
166
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
T-2345
T-2345 Ophthalmic Solution
|
Xalatan
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Ran out of IP and decided to discontinue
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
T-2345
n=164 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=170 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
66.1 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
66.5 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
170 participants
n=7 Participants
|
334 participants
n=5 Participants
|
|
Corneal thickness, study eye (μm)
|
550.7 μm
STANDARD_DEVIATION 33.9 • n=5 Participants
|
548.7 μm
STANDARD_DEVIATION 34.5 • n=7 Participants
|
549.6 μm
STANDARD_DEVIATION 34.2 • n=5 Participants
|
|
Corneal thickness, fellow eye (μm)
|
552.1 μm
STANDARD_DEVIATION 33.7 • n=5 Participants
|
549.4 μm
STANDARD_DEVIATION 33.6 • n=7 Participants
|
550.7 μm
STANDARD_DEVIATION 33.6 • n=5 Participants
|
|
Shaffer angle by gonioscopy, study eye
Schaffer Angle Grade III
|
83 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Shaffer angle by gonioscopy, study eye
Schaffer Angle Grade IV
|
81 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Shaffer angle by gonioscopy, fellow eye
Schaffer Angle Grade III
|
83 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Shaffer angle by gonioscopy, fellow eye
Schaffer Angle Grade IV
|
81 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84Population: The Per Protocol population was the primary efficacy population and consisted of those subjects in the ITT population who had no major protocol violations and no missing data points
Evaluation of intraocular pressure using Goldmann applanation tonometry. Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points. Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points
Outcome measures
| Measure |
T-2345
n=161 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=164 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Intraocular Pressure
Day 15 08:00
|
-3.0 mm Hg
Standard Deviation 3.2
|
-3.8 mm Hg
Standard Deviation 3.4
|
|
Intraocular Pressure
Day 42 16:00
|
-2.3 mm Hg
Standard Deviation 2.9
|
-3.1 mm Hg
Standard Deviation 3.4
|
|
Intraocular Pressure
Day 84 08:00
|
-3.0 mm Hg
Standard Deviation 3.2
|
-3.5 mm Hg
Standard Deviation 3.2
|
|
Intraocular Pressure
Day 84 16:00
|
-2.2 mm Hg
Standard Deviation 2.8
|
-2.9 mm Hg
Standard Deviation 3.2
|
|
Intraocular Pressure
Day 15 10:00
|
-2.7 mm Hg
Standard Deviation 2.9
|
-3.6 mm Hg
Standard Deviation 3.3
|
|
Intraocular Pressure
Day 15 16:00
|
-2.3 mm Hg
Standard Deviation 2.8
|
-3.1 mm Hg
Standard Deviation 3.3
|
|
Intraocular Pressure
Day 42 08:00
|
-3.0 mm Hg
Standard Deviation 3.2
|
-3.5 mm Hg
Standard Deviation 3.2
|
|
Intraocular Pressure
Day 42 10:00
|
-2.7 mm Hg
Standard Deviation 3.1
|
-3.5 mm Hg
Standard Deviation 3.4
|
|
Intraocular Pressure
Day 84 10:00
|
-2.7 mm Hg
Standard Deviation 3.0
|
-3.6 mm Hg
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 84 daysPopulation: Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.
Visual Acuity was measured using the Corrected Snellen Visual Acuity method reported as the Logarithm Minimum Angle of Resoution (logMAR) change from baseline. The Snellen eye chart was used with the subject's current corrected lens prescription at a distance equivalent to 20 feet. Results from the Snellen chart were converted to the logMAR scale which is the standard tool for reporting visual acuity outcomes.
Outcome measures
| Measure |
T-2345
n=165 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=169 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Visual Acuity
|
-0.003 logMAR units
Standard Deviation 0.075
|
-0.008 logMAR units
Standard Deviation 0.082
|
SECONDARY outcome
Timeframe: Baseline and 84 daysPopulation: Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.
Number of participants with eye abnormalities following routine slit lamp examination. The anterior segment of the eye including lids, cornea, conjunctiva, anterior chamber, iris and lens were evaluated with a routine slit lamp examination and any abnormalities observed were reported.
Outcome measures
| Measure |
T-2345
n=165 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=169 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Slit Lamp Examination
Cornea
|
1 Participants
|
2 Participants
|
|
Slit Lamp Examination
Conjunctiva
|
2 Participants
|
2 Participants
|
|
Slit Lamp Examination
Lid
|
4 Participants
|
0 Participants
|
|
Slit Lamp Examination
Iris
|
0 Participants
|
1 Participants
|
|
Slit Lamp Examination
Lens
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 84 daysPopulation: Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.
Number of participants with eye abnormalities following ophthalmoscopy. Direct ophthalmoscopy with dilation included assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina was conducted. Results are reported as the number of subjects with clinical significant abnormalities at Day 84 that were not clinically significant at Baseline.
Outcome measures
| Measure |
T-2345
n=165 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=169 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Ophthalmoscopy
Study eye
|
1 Participants
|
0 Participants
|
|
Ophthalmoscopy
Fellow eye
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 84 daysPopulation: Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.
Visual Field was performed using an automated perimeter according to the sites standard protocol. This test measures the angle of the visual field from the central visual axis. Visual Field Testing generates a numerical scale as its main result which shows the retinal sensitivities at the different test locations, expressed in Decibels (dB). The mean deviation in the visual field reflects the overall depression (deviation from normal values). Negative values indicate a reduction in visual field. The analysis performed is the mean change from baseline at Day 84.
Outcome measures
| Measure |
T-2345
n=165 Participants
T-2345 Ophthalmic Solution
|
Xalatan
n=169 Participants
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Mean Deviation in Visual Field
Study eye
|
-0.169 Decibels (dB)
Standard Deviation 1.607
|
-0.166 Decibels (dB)
Standard Deviation 1.680
|
|
Mean Deviation in Visual Field
Fellow eye
|
0.067 Decibels (dB)
Standard Deviation 2.124
|
-0.094 Decibels (dB)
Standard Deviation 1.466
|
Adverse Events
T-2345
Xalatan
Serious adverse events
| Measure |
T-2345
n=165 participants at risk
T-2345 Ophthalmic Solution
|
Xalatan
n=169 participants at risk
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.61%
1/165 • Number of events 1 • 84 days
|
0.00%
0/169 • 84 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/165 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/165 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/165 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
|
Nervous system disorders
Basal ganglia stroke
|
0.00%
0/165 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
Other adverse events
| Measure |
T-2345
n=165 participants at risk
T-2345 Ophthalmic Solution
|
Xalatan
n=169 participants at risk
Xalatan (Latanoprost 0.005% Ophthalmic Solution)
|
|---|---|---|
|
Eye disorders
Conjunctival hyperemia
|
1.8%
3/165 • Number of events 3 • 84 days
|
2.4%
4/169 • Number of events 4 • 84 days
|
|
Eye disorders
Blepharitis
|
1.2%
2/165 • Number of events 2 • 84 days
|
3.0%
5/169 • Number of events 5 • 84 days
|
|
Eye disorders
Punctate keratitis
|
0.61%
1/165 • Number of events 1 • 84 days
|
3.0%
5/169 • Number of events 5 • 84 days
|
|
Eye disorders
Vitreous detachment
|
0.61%
1/165 • Number of events 1 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/165 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/165 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/165 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
General disorders
Instillation site pain
|
1.8%
3/165 • Number of events 3 • 84 days
|
4.7%
8/169 • Number of events 8 • 84 days
|
|
General disorders
Instillation site pruritus
|
1.2%
2/165 • Number of events 2 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
|
General disorders
Instillation site abnormal sensation
|
0.61%
1/165 • Number of events 1 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
General disorders
instillation site complication
|
0.00%
0/165 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/165 • Number of events 3 • 84 days
|
0.00%
0/169 • 84 days
|
|
Infections and infestations
Sinusitis
|
1.2%
2/165 • Number of events 2 • 84 days
|
0.00%
0/169 • 84 days
|
|
Infections and infestations
Bronchitis
|
0.61%
1/165 • Number of events 1 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Infections and infestations
Nasopharyngitis
|
0.61%
1/165 • Number of events 1 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/165 • Number of events 2 • 84 days
|
0.59%
1/169 • Number of events 1 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/165 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.61%
1/165 • Number of events 1 • 84 days
|
1.2%
2/169 • Number of events 2 • 84 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place