Trial Outcomes & Findings for Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (NCT NCT00486252)

Last Updated: 2021-03-01

Results Overview

Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

Recruitment status

COMPLETED

Target enrollment

996 participants

Primary outcome timeframe

Baseline, Month 3

Results posted on

2021-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Latanoprost All Subjects Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Overall Study STARTED	996
Overall Study COMPLETED	938
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Latanoprost All Subjects Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	9
Overall Study Lost to Follow-up	24
Overall Study Other	18

Baseline Characteristics

Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Latanoprost All Subjects n=996 Participants Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Age, Continuous	61.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex/Gender, Customized Male	395 participants n=5 Participants
Sex/Gender, Customized Female	596 participants n=5 Participants
Sex/Gender, Customized Unspecified	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. "n"=number of participants in each group for that category.

Outcome measures

Outcome measures
Measure	Latanoprost (All Subjects) n=945 Participants Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanoprost (no Prior Beta-blocker Therapy) n=402 Participants Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanaprost (Prior Beta-blocker Failure) n=531 Participants Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Change in Intraocular Pressure (IOP): Baseline to Month 3	-5.3 mmHg Standard Deviation 3.9	-6.8 mmHg Standard Deviation 3.8	-4.1 mmHg Standard Deviation 3.5

SECONDARY outcome

Timeframe: Month 1, Month 3

Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.

Outcome measures

Outcome measures
Measure	Latanoprost (All Subjects) n=945 Participants Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanoprost (no Prior Beta-blocker Therapy) n=402 Participants Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanaprost (Prior Beta-blocker Failure) n=531 Participants Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Percentage Change in Intraocular Pressure (IOP) Month 1 (n=982, 419, 551)	-19.2 percentage change in mmHg Standard Deviation 20.9	-22.6 percentage change in mmHg Standard Deviation 28.0	-16.5 percentage change in mmHg Standard Deviation 12.7
Percentage Change in Intraocular Pressure (IOP) Month 3 (n=945, 402, 531)	-21.5 percentage change in mmHg Standard Deviation 22.2	-26.1 percentage change in mmHg Standard Deviation 29.0	-18.1 percentage change in mmHg Standard Deviation 14.5

SECONDARY outcome

Timeframe: Month 1, Month 3

Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change \< 0); Percentage reduction greater than 20% (percentage change \< -20).

Outcome measures

Outcome measures
Measure	Latanoprost (All Subjects) n=990 Participants Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanoprost (no Prior Beta-blocker Therapy) n=422 Participants Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanaprost (Prior Beta-blocker Failure) n=556 Participants Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Categorized Percentage Change in Intraocular Pressure (IOP) Month 1: Increase or no change in IOP	69 participants	10 participants	58 participants
Categorized Percentage Change in Intraocular Pressure (IOP) Month 1: Percentage reduction of up to 20%	422 participants	145 participants	274 participants
Categorized Percentage Change in Intraocular Pressure (IOP) Month 1: Percentage reduction of greater than 20%	491 participants	264 participants	219 participants
Categorized Percentage Change in Intraocular Pressure (IOP) Month 3: Increase or no change in IOP	62 participants	12 participants	50 participants
Categorized Percentage Change in Intraocular Pressure (IOP) Month 3: Percentage reduction of up to 20%	312 participants	90 participants	217 participants
Categorized Percentage Change in Intraocular Pressure (IOP) Month 3: Percentage reduction of greater than 20%	571 participants	300 participants	264 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 1

Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

Outcome measures

Outcome measures
Measure	Latanoprost (All Subjects) n=982 Participants Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanoprost (no Prior Beta-blocker Therapy) n=419 Participants Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.	Latanaprost (Prior Beta-blocker Failure) n=551 Participants Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Change in Intraocular Presssure (IOP): Baseline to Month 1	-4.7 mmHg Standard Deviation 3.4	-5.9 mmHg Standard Deviation 3.5	-3.7 mmHg Standard Deviation 3.0

Adverse Events

Latanoprost All Subjects

Serious events: 0 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Latanoprost All Subjects n=996 participants at risk Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
Eye disorders Abnormal sensation in eye	0.10% 1/996
Eye disorders Conjunctival hyperaemia	1.1% 11/996
Eye disorders Conjunctival irritation	0.10% 1/996
Eye disorders Conjunctival oedema	0.10% 1/996
Eye disorders Conjunctival pigmentation	0.10% 1/996
Eye disorders Conjunctivitis	0.30% 3/996
Eye disorders Dry eye	0.10% 1/996
Eye disorders Erythema of eyelid	0.40% 4/996
Eye disorders Eye irritation	0.10% 1/996
Eye disorders Eye pain	0.10% 1/996
Eye disorders Eyelash discolouration	0.20% 2/996
Eye disorders Keratoconjunctivitis sicca	0.10% 1/996
Eye disorders Sicca syndrome	0.20% 2/996
Eye disorders Visual disturbance	0.10% 1/996
General disorders Adverse event	3.4% 34/996
Investigations Blood pressure decreased	0.10% 1/996
Nervous system disorders Headache	0.10% 1/996
Nervous system disorders Paraesthesia	0.10% 1/996
Vascular disorders Hyperaemia	6.2% 62/996

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Publication restrictions are in place

Restriction type: OTHER