Trial Outcomes & Findings for Efficacy and Tolerability of Xalatan in Patients (NCT NCT00950690)
NCT ID: NCT00950690
Last Updated: 2021-02-25
Results Overview
Intraocular pressure was measured at each visit
Recruitment status
COMPLETED
Target enrollment
1289 participants
Primary outcome timeframe
Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Results posted on
2021-02-25
Participant Flow
Investigative sites
Participant milestones
| Measure |
Xalatan
0.005% ophthalmic solution dosed once daily for 3 months
|
|---|---|
|
Overall Study
STARTED
|
1349
|
|
Overall Study
COMPLETED
|
1105
|
|
Overall Study
NOT COMPLETED
|
244
|
Reasons for withdrawal
| Measure |
Xalatan
0.005% ophthalmic solution dosed once daily for 3 months
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Lost to Follow-up
|
40
|
|
Overall Study
Other
|
163
|
Baseline Characteristics
Efficacy and Tolerability of Xalatan in Patients
Baseline characteristics by cohort
| Measure |
Xalatan
n=1349 Participants
0.005% ophthalmic solution dosed once daily for 3 months
|
|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 13.0 • n=113 Participants
|
|
Sex/Gender, Customized
Male
|
723 Participants
n=113 Participants
|
|
Sex/Gender, Customized
Female
|
584 Participants
n=113 Participants
|
|
Sex/Gender, Customized
Unspecified
|
42 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Screening, 10 days, 4 weeks and 12 weeks after beginning treatmentPopulation: Data collection process did not permit clear identification of IOP \& visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.
Intraocular pressure was measured at each visit
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visits 1 and 4Population: Data collection process did not permit clear identification of IOP \& visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.
Analysis of visual field deficits for abnormalities.
Outcome measures
Outcome data not reported
Adverse Events
Xalatan
Serious events: 5 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xalatan
0.005% ophthalmic solution dosed once daily for 3 months
|
|---|---|
|
Eye disorders
Iridocyclitis
|
0.07%
1/1349
|
|
Eye disorders
Retinal detachment
|
0.07%
1/1349
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1349
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.07%
1/1349
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.07%
1/1349
|
Other adverse events
| Measure |
Xalatan
0.005% ophthalmic solution dosed once daily for 3 months
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.07%
1/1349
|
|
Ear and labyrinth disorders
Ear Pain
|
0.07%
1/1349
|
|
Eye disorders
Conjunctival follicles
|
0.07%
1/1349
|
|
Eye disorders
Conjunctival hyperaemia
|
0.52%
7/1349
|
|
Eye disorders
Conjunctivitis
|
0.15%
2/1349
|
|
Eye disorders
Corneal erosion
|
0.15%
2/1349
|
|
Eye disorders
Dry eye
|
0.30%
4/1349
|
|
Eye disorders
Eye disorder
|
0.30%
4/1349
|
|
Eye disorders
Eye irritation
|
0.07%
1/1349
|
|
Eye disorders
Eye pain
|
0.07%
1/1349
|
|
Eye disorders
Glaucoma
|
0.07%
1/1349
|
|
Eye disorders
Ocular hyperaemia
|
0.52%
7/1349
|
|
Eye disorders
Uveitis
|
0.07%
1/1349
|
|
General disorders
Condition aggravated
|
0.07%
1/1349
|
|
General disorders
Drug effect decreased
|
0.07%
1/1349
|
|
General disorders
Drug ineffective
|
0.07%
1/1349
|
|
General disorders
Ill-defined disorder
|
1.6%
22/1349
|
|
General disorders
Pain
|
0.07%
1/1349
|
|
Infections and infestations
Human ehrlichiosis
|
0.07%
1/1349
|
|
Investigations
Intraocular pressure increased
|
0.07%
1/1349
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.07%
1/1349
|
|
Nervous system disorders
Burning sensation
|
0.07%
1/1349
|
|
Nervous system disorders
Headache
|
0.07%
1/1349
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
2/1349
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.07%
1/1349
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.07%
1/1349
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.67%
9/1349
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.22%
3/1349
|
|
Vascular disorders
Hyperaemia
|
1.4%
19/1349
|
|
Vascular disorders
Hypertension
|
0.07%
1/1349
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1349
|
Additional Information
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