An observational study in Glaucoma,Open-Angle and Ocular Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational
The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 996 is above the median of 103 across 454 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension
Exclusion Criteria:
This is N/A due to the above description.
Other: Observational
This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.
Change in Intraocular Pressure (IOP): Baseline to Month 3
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.
Time frame: Baseline, Month 3
Percentage Change in Intraocular Pressure (IOP)
Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.
Time frame: Month 1, Month 3
Categorized Percentage Change in Intraocular Pressure (IOP)
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).
Time frame: Month 1, Month 3
Change in Intraocular Presssure (IOP): Baseline to 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.
Time frame: Baseline, Month 1
| Milestone | Latanoprost All Subjects |
|---|---|
| Started | 996 |
| Completed | 938 |
| Not completed | 58 |
| Withdrew: Adverse event | 7 |
| Withdrew: Lack of efficacy | 9 |
| Withdrew: Lost to follow-up | 24 |
| Withdrew: Other | 18 |
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.
| mmHg | Latanoprost (All Subjects) | Latanoprost (no Prior Beta-blocker Therapy) | Latanaprost (Prior Beta-blocker Failure) |
|---|---|---|---|
| Change in Intraocular Pressure (IOP): Baseline to Month 3 | -5.3 ± 3.9 | -6.8 ± 3.8 | -4.1 ± 3.5 |
Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.
| percentage change in mmHg | Latanoprost (All Subjects) | Latanoprost (no Prior Beta-blocker Therapy) | Latanaprost (Prior Beta-blocker Failure) |
|---|---|---|---|
| Month 1 (n=982, 419, 551) | -19.2 ± 20.9 | -22.6 ± 28.0 | -16.5 ± 12.7 |
| Month 3 (n=945, 402, 531) | -21.5 ± 22.2 | -26.1 ± 29.0 | -18.1 ± 14.5 |
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).
| participants | Latanoprost (All Subjects) | Latanoprost (no Prior Beta-blocker Therapy) | Latanaprost (Prior Beta-blocker Failure) |
|---|---|---|---|
| Month 1: Increase or no change in IOP | 69 | 10 | 58 |
| Month 1: Percentage reduction of up to 20% | 422 | 145 | 274 |
| Month 1: Percentage reduction of greater than 20% | 491 | 264 | 219 |
| Month 3: Increase or no change in IOP | 62 | 12 | 50 |
| Month 3: Percentage reduction of up to 20% | 312 | 90 | 217 |
| Month 3: Percentage reduction of greater than 20% | 571 | 300 | 264 |
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.
| mmHg | Latanoprost (All Subjects) | Latanoprost (no Prior Beta-blocker Therapy) | Latanaprost (Prior Beta-blocker Failure) |
|---|---|---|---|
| Change in Intraocular Presssure (IOP): Baseline to Month 1 | -4.7 ± 3.4 | -5.9 ± 3.5 | -3.7 ± 3.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Latanoprost All Subjects | — | 0/996 (0%) | — |
| Event | Latanoprost All Subjects |
|---|---|
| HyperaemiaVascular disorders | 62/996 |
| Adverse eventGeneral disorders | 34/996 |
| Conjunctival hyperaemiaEye disorders | 11/996 |
| Erythema of eyelidEye disorders | 4/996 |
| ConjunctivitisEye disorders | 3/996 |
| Eyelash discolourationEye disorders | 2/996 |
| Sicca syndromeEye disorders | 2/996 |
| Abnormal sensation in eyeEye disorders | 1/996 |
| Conjunctival irritationEye disorders | 1/996 |
| Conjunctival oedemaEye disorders | 1/996 |
| Age, Continuous(years) | Latanoprost All Subjects |
|---|---|
| Mean | 61.7 ± 13.4 |
| Sex/Gender, Customized(participants) | Latanoprost All Subjects |
|---|---|
| Male | 395 |
| Female | 596 |
| Unspecified | 5 |
No study locations are listed for this record.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.