Europe · Phase III and Phase II/III · Topical ophthalmic and eye-drop trials
EU Phase III topical ophthalmic and eye-drop trials: sites, PIs, CROs and recruitment plans
Ospedale San Raffaele leads the Phase III topical ophthalmic site network with six trial participations, while Francesco Bandello leads investigator experience with six. Across 14 Phase III-containing studies, 198 distinct listed sites and 235 named investigators span 17 European countries. Parexel leads documented CRO support across three programs, and the largest current authorised EU recruitment allocation reaches 950 participants.
Top sites · 14 Phase III-containing topical ophthalmic studies
San Raffaele leads the Phase III eye-drop site network
Ospedale San Raffaele contributed to six studies. Fondazione Bietti, Instituto de Microcirugía Ocular and Fernandez-Vega each contributed to four, followed by Federico II in Naples with three.
Trial participation reflects documented ophthalmic study experience, not current recruitment capacity or site performance.
Top investigators · 14 Phase III-containing topical ophthalmic studies
Francesco Bandello leads with six Phase III trial participations
Berthold Seitz and Jose Luis Güell Villanueva each contributed to five studies. Gerd Geerling and Luigi Fontana each contributed to four.
Current EU recruitment plans · Phase III topical ophthalmic studies
The largest Phase III eye-drop programs plan hundreds of European participants
The citicoline glaucoma study carries the largest current authorised EU allocation at 950 participants. FAST 7 follows at 536, while STN1013800 carries 343 participants across its current EU country allocations.
Country allocations are planned recruitment figures, not completed enrollment. They are not interchangeable with a study's final global sample size.
Operational CRO experience · 14 Phase III-containing topical ophthalmic studies
Parexel leads documented Phase III operational support
Parexel supports three studies. ICON, OPIS and Pharmassist each support two, followed by BECRO with one.
CRO recurrence indicates documented operational experience, not CRO quality or performance.
Operational finding · LIDRISE Phase III
Germany never opened recruitment and was later ended for feasibility
In Santen’s Phase III LIDRISE study of STN1013800 for acquired blepharoptosis, Germany was planned for one site and 10 participants. Recruitment never started there, and CTIS records an early termination on 13 August 2025 for “Feasibility (recruitment issues, etc)”.
Five new sites and 52 planned participants were added after the German failure
Germany’s only listed site was Universitätsmedizin Göttingen. After the German country arm ended, Bulgaria and Romania were added through Additional Member State applications in 2026. Bulgaria contributed three sites and a 32-participant plan, while Romania contributed two sites and 20 participants.
The overall CTIS plan totals 380 participants, with 343 allocated across EU countries and 37 in the United Kingdom. CTIS does not label Bulgaria and Romania as formal replacements for Germany, but operationally the program added five sites and 52 planned participants after the one-site, 10-participant German plan failed to recruit.
Source: CTIS trial records, current authorised country recruitment plans, site and investigator records, third-party organisation roles and lifecycle events, reviewed 20 September 2026. The landscape covers 14 European Phase III-containing topical ophthalmic and eye-drop studies, including one Phase II/III program.