Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

• Sponsor: Nephron Pharmaceuticals Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02059278
• Collaborator: (none)
• Enrollment: 335
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension	Drug: T-2345; Drug: Xalatan	Phase 3

Detailed Description

The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH).

This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks.

Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits.

Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection.

Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits.

Secondary Efficacy Endpoints include:

• Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits.

• Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.

Study Design

• Study Type: Interventional
• Actual Enrollment: 335 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Parallel-Group, Observer-Masked, Phase 3 Study to Compare the Safety and Efficacy of T-2345 Ophthalmic Solution to Xalatan (Latanoprost 0.005%) in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T-2345 T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)	Drug: T-2345; T-2345 Ophthalmic Solution
Experimental: Xalatan Xalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)	Drug: Xalatan; Xalatan (latanoprost 0.005% ophthalmic solution)

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84]

   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

Secondary Outcome Measures

1. Visual Acuity [Baseline and 84 days]

   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.

2. Slit Lamp Examination [Baseline and 84 days]

   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.

3. Ophthalmoscopy [Baseline and 84 days]

   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.

4. Mean Deviation in Visual Field [Baseline and 84 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years or older.

2. POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.

3. Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.

4. Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal

VF examination, the following criteria apply:

• Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months and ≤ 18 months apart must be compared;

• The most recent VF examination should be performed < 6 months prior to the Screening visit;

• The past VF examination should be performed ≥ 6 months and ≤ 18 months prior to the most recent VF test.

1. Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye. Patients must see ≥ 50% of the letters on a single line to accept that VA line.

2. Central corneal thickness 480-620 μm in the study eye.

3. Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.

4. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Screening. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

5. All subjects must provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

In the study eye:

1. A mean deviation of < -20 dB on VF examination.

2. A mean IOP ˃ 28 mm Hg at Baseline.

3. Presence of a scotoma within 5° of fixation on VF examination.

4. Aphakia.

5. Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic solution within 2 weeks prior to Screening and any antiglaucoma medication (other than latanoprost) during the study period other than the randomized study medication.

6. Use of any topical ophthalmic steroid within 2 weeks prior to Baseline. A short course of oral steroids is acceptable if the course is completed > 2 weeks prior to Screening. Inhaled and intranasal steroids are acceptable.

7. Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Baseline.

8. Use of any ophthalmic medications during the study period (nonpreserved artificial tears are allowed).

9. Ocular surgery or laser treatment of any kind in the study eye within 3 months prior to Baseline.

10. History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on the lid is acceptable.

11. History of ocular trauma or ocular infection within 3 months of Screening.

12. History of herpes simplex keratitis.

13. Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.

14. Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day).

15. Contact lens wear during the study period. Contact lens wear in an untreated fellow eye is allowed.

16. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).

17. Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).

18. Any non-laser glaucoma surgery.

19. Any abnormality preventing accurate assessment (eg, resulting in unreliable applanation tonometry or VF examination).

General:

1. Pregnancy or lactation.

2. Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy).

3. Allergy to benzalkonium chloride.

4. History of moderate or severe renal or hepatic impairment.

5. Participation in any study of an investigational product within 30 days prior to Screening or at any time during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		El Paso	Texas	United States

Sponsors and Collaborators

• Nephron Pharmaceuticals Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nephron Pharmaceuticals Corporation
• ClinicalTrials.gov Identifier: NCT02059278
• Other Study ID Numbers: T-2345-001
• First Posted: Feb 11, 2014
• Last Update Posted: Aug 22, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Nephron Pharmaceuticals Corporation: Primary open angle glaucoma; Ocular hypertension
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Latanoprost

Study Results

Participant Flow

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Period Title: Overall Study
STARTED	165	170
COMPLETED	162	166
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	T-2345	Xalatan	Total
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)	Total of all reporting groups
Overall Participants	164	170	334
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.1 (10.2)	66.1 (11.0)	66.5 (10.6)
Sex: Female, Male (Count of Participants)
Female	104 63.4%	100 58.8%	204 61.1%
Male	60 36.6%	70 41.2%	130 38.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 11%	22 12.9%	40 12%
Not Hispanic or Latino	146 89%	148 87.1%	294 88%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.6%	0 0%	1 0.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	37 22.6%	28 16.5%	65 19.5%
White	125 76.2%	141 82.9%	266 79.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.6%	1 0.6%	2 0.6%
Region of Enrollment (participants) [Number]
United States	164 100%	170 100%	334 100%
Corneal thickness, study eye (μm) (μm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μm]	550.7 (33.9)	548.7 (34.5)	549.6 (34.2)
Corneal thickness, fellow eye (μm) (μm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μm]	552.1 (33.7)	549.4 (33.6)	550.7 (33.6)
Shaffer angle by gonioscopy, study eye (Count of Participants)
Schaffer Angle Grade III	83 50.6%	84 49.4%	167 50%
Schaffer Angle Grade IV	81 49.4%	86 50.6%	167 50%
Shaffer angle by gonioscopy, fellow eye (Count of Participants)
Schaffer Angle Grade III	83 50.6%	84 49.4%	167 50%
Schaffer Angle Grade IV	81 49.4%	86 50.6%	167 50%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure
Description	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
Time Frame	Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Measure Participants	161	164
Day 15 08:00	-3.0 (3.2)	-3.8 (3.4)
Day 15 10:00	-2.7 (2.9)	-3.6 (3.3)
Day 15 16:00	-2.3 (2.8)	-3.1 (3.3)
Day 42 08:00	-3.0 (3.2)	-3.5 (3.2)
Day 42 10:00	-2.7 (3.1)	-3.5 (3.4)
Day 42 16:00	-2.3 (2.9)	-3.1 (3.4)
Day 84 08:00	-3.0 (3.2)	-3.5 (3.2)
Day 84 10:00	-2.7 (3.0)	-3.6 (3.1)
Day 84 16:00	-2.2 (2.8)	-2.9 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 8 am on Day 15
Statistical Test of Hypothesis	p-Value	0.0091
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.781
	Confidence Interval	(2-Sided) 95%; 0.195 to 1.366
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 8 am on Day 15

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 10 am on Day 15
Statistical Test of Hypothesis	p-Value	0.0098
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.664
	Confidence Interval	(2-Sided) 95%; 0.161 to 1.167
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 10 am on Day 15

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 4 pm on Day 15
Statistical Test of Hypothesis	p-Value	0.0398
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.542
	Confidence Interval	(2-Sided) 95%; 0.025 to 1.058
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 4 pm on Day 15

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 8 am on Day 42
Statistical Test of Hypothesis	p-Value	0.1008
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.478
	Confidence Interval	(2-Sided) 95%; -0.093 to 1.050
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 8 am on Day 42

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 10 am on Day 42
Statistical Test of Hypothesis	p-Value	0.0558
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.505
	Confidence Interval	(2-Sided) 95%; -0.013 to 1.024
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 10 am on Day 42

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 4 pm on Day 42
Statistical Test of Hypothesis	p-Value	0.0491
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.538
	Confidence Interval	(2-Sided) 95%; 0.002 to 1.074
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 4 pm on Day 42

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 8 am on Day 84
Statistical Test of Hypothesis	p-Value	0.0025
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.808
	Confidence Interval	(2-Sided) 95%; 0.286 to 1.329
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 8 am on Day 84

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 10 am on Day 84
Statistical Test of Hypothesis	p-Value	0.0113
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.627
	Confidence Interval	(2-Sided) 95%; 0.143 to 1.111
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 10 am on Day 84

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	T-2345, Xalatan
	Comments	The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.
	Type of Statistical Test	Equivalence
	Comments	Analysis at 4 pm on Day 84
Statistical Test of Hypothesis	p-Value	0.0649
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.456
	Confidence Interval	(2-Sided) 95%; -0.063 to 0.975
	Parameter Dispersion	Type: Value:
	Estimation Comments	ANCOVA on change from baseline at 4 pm on Day 84

2. Secondary Outcome

Title	Visual Acuity
Description	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.
Time Frame	Baseline and 84 days

Outcome Measure Data

Analysis Population Description

Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Measure Participants	165	169
Mean (Standard Deviation) [logMAR units]	-0.003 (0.075)	-0.008 (0.082)

3. Secondary Outcome

Title	Slit Lamp Examination
Description	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.
Time Frame	Baseline and 84 days

Outcome Measure Data

Analysis Population Description

Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Measure Participants	165	169
Lid	4 2.4%	0 0%
Cornea	1 0.6%	2 1.2%
Conjunctiva	2 1.2%	2 1.2%
Iris	0 0%	1 0.6%
Lens	3 1.8%	6 3.5%

4. Secondary Outcome

Title	Ophthalmoscopy
Description	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.
Time Frame	Baseline and 84 days

Outcome Measure Data

Analysis Population Description

Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Measure Participants	165	169
Study eye	1 0.6%	0 0%
Fellow eye	1 0.6%	0 0%

5. Secondary Outcome

Title	Mean Deviation in Visual Field
Description	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.
Time Frame	Baseline and 84 days

Outcome Measure Data

Analysis Population Description

Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.

Arm/Group Title	T-2345	Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution	Xalatan (Latanoprost 0.005% Ophthalmic Solution)
Measure Participants	165	169
Study eye	-0.169 (1.607)	-0.166 (1.680)
Fellow eye	0.067 (2.124)	-0.094 (1.466)

Adverse Events

Time Frame	84 days
Arm/Group Title	T-2345		Xalatan
Arm/Group Description	T-2345 Ophthalmic Solution		Xalatan (Latanoprost 0.005% Ophthalmic Solution)
All Cause Mortality
	T-2345		Xalatan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/165 (0%)		1/169 (0.6%)
Serious Adverse Events
	T-2345		Xalatan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/165 (0.6%)		4/169 (2.4%)
Hepatobiliary disorders
Cholelithiasis	1/165 (0.6%)	1	0/169 (0%)	0
Injury, poisoning and procedural complications
Spinal compression fracture	0/165 (0%)	0	1/169 (0.6%)	1
Wound dehiscence	0/165 (0%)	0	1/169 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma	0/165 (0%)	0	1/169 (0.6%)	1
Nervous system disorders
Basal ganglia stroke	0/165 (0%)	0	1/169 (0.6%)	1
Other (Not Including Serious) Adverse Events
	T-2345		Xalatan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/165 (13.9%)		44/169 (26%)
Eye disorders
Conjunctival hyperemia	3/165 (1.8%)	3	4/169 (2.4%)	4
Blepharitis	2/165 (1.2%)	2	5/169 (3%)	5
Punctate keratitis	1/165 (0.6%)	1	5/169 (3%)	5
Vitreous detachment	1/165 (0.6%)	1	2/169 (1.2%)	2
Conjunctival cyst	0/165 (0%)	0	2/169 (1.2%)	2
Conjunctival hemorrhage	0/165 (0%)	0	2/169 (1.2%)	2
Conjunctivitis allergic	0/165 (0%)	0	2/169 (1.2%)	2
General disorders
Instillation site pain	3/165 (1.8%)	3	8/169 (4.7%)	8
Instillation site pruritus	2/165 (1.2%)	2	1/169 (0.6%)	1
Instillation site abnormal sensation	1/165 (0.6%)	1	2/169 (1.2%)	2
instillation site complication	0/165 (0%)	0	2/169 (1.2%)	2
Infections and infestations
Urinary tract infection	3/165 (1.8%)	3	0/169 (0%)	0
Sinusitis	2/165 (1.2%)	2	0/169 (0%)	0
Bronchitis	1/165 (0.6%)	1	2/169 (1.2%)	2
Nasopharyngitis	1/165 (0.6%)	1	2/169 (1.2%)	2
Musculoskeletal and connective tissue disorders
Back pain	2/165 (1.2%)	2	1/169 (0.6%)	1
Muscle spasms	0/165 (0%)	0	2/169 (1.2%)	2
Sciatica	1/165 (0.6%)	1	2/169 (1.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.