Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Xalatan

Study drug International non-proprietary name (INN) or common name

LATANOPROST

Medical condition to be studied

Glaucoma drug therapy
Ocular hypertension
Population studied

Short description of the study population

No minimum number of subjects is planned in this study. The number (i.e., 23) is estimated based on the number of subjects enrolled into the A6111143 study (178 subjects) and hypothetical discontinuation rate in the A6111143 (50%), participation rates in the A6111144 study (50%) and discontinuation rate in the A6111144 studies (50%).

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)

Estimated number of subjects

23
Study design details

Main study objective

To describe the incidence (proportion and rate) of hyperpigmentation changes in the eye over a total of a 10-year follow-up period by combining the data collected in the 3-year A6111143 study and the subsequent 7-year A6111144 study, among pediatric patients with glaucoma or elevated intraocular pressure who have completed the 3-year A6111143 study.

Outcomes

Hyperpigmentation changes in the eye(s)

Data analysis plan

Data analysis will be performed for the entire 10-year follow-up period for all patients enrolled in the A6111144 study. Patient demographics (eg, age and sex) and clinical characteristics (eg, diagnosis of glaucoma) will be summarized for patients in latanoprost treatment group and non topical PGA treatment group. The number and proportion of patients who discontinue participation, and the reasons for discontinuation will be summarized by year for the 10-year period. Incidence number and incidence proportion of hyperpigmentation of the eye will be calculated by study groups as appropriate. Incidence number is the total number of patients that experience at least 1 notable increase of hyperpigmentation of the eye in at least one follow-up visit over 10 years. Incidence proportion is the percentage of patients that experience at least 1 notable increase of hyperpigmentation of the eye in at least one follow-up visit over 10 years. Incidence rate will also be estimated as appropriate.