CompletedPhase 3

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

United States139 participantsStarted 2008-07

Plain-language summary

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Who can participate

Age range36 Weeks – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female of 18 years of age or under * Diagnosis of glaucoma * IOP of 22 mmHg or above in at least 1 eye Exclusion Criteria: * Require surgery for acute angle closure * Have had prior cyclodestructive procedures * Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

What they're measuring

Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT00716859

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2010-11-01

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