N/A
N=175
Long-Term Non-Interventional Latanoprost Study
Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01265719 ↗Enrolled (actual)
175
Serious AEs
7.5%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) — 0.25; -0.07; 0.01; 0.04 logMar — p=0.1126
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention other than routine medical care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) |
0.25; -0.07; 0.01; 0.04 | 0.1126 |
| SECONDARY Number of Participants With Clinically Meaningful Change in Refractive Error |
8; 2 | — |
| SECONDARY Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler) |
0.33; 0.37; 0.08; 0.05 | 0.9020 |
| SECONDARY Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) |
-1.01; 0.61; 1.52; 1.62; -4.26; 2.40 | 0.2003 |
| SECONDARY Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios |
1; 0 | >0.999 |
| SECONDARY Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects. |
1; 1 | >0.999 |
| SECONDARY Iris Color Darkening |
4; 2 | >0.999 |
| SECONDARY Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid |
3; 3 | — |
| SECONDARY Eyelash Darkening/Thickening |
3; 1 | 0.6414 |
| SECONDARY Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) |
1.14; 0.53; 0.44; 0.65 | 0.2437 |
| SECONDARY Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) |
-8.67; -5.99; 5.30; 6.17 | 0.8643 |
| SECONDARY Conjunctival/Ocular Hyperemia |
6; 1 | 0.2413 |
| SECONDARY Number of Participants With a Change in Anterior Segment Biomicroscopy |
0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline |
3; 1; 43; 29; 12; 1 | — |
Summary
This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.
Eligibility Criteria
Inclusion Criteria
- Male or female <18 years of age (neonates must be at least 36 weeks gestational age).
- Diagnosis of pediatric glaucoma or elevated intraocular pressure.
- Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws.
For treated subjects only:
- Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination.
For untreated subjects only:
- Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR
- No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.
Exclusion Criteria
- Unable/unwilling to comply with protocol.
- Pregnant or nursing females at baseline.
- For treated subjects only: a history of allergy or hypersensitivity to any of the ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium chloride).
Data sourced from ClinicalTrials.gov (NCT01265719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.