Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Status:
Terminated
Trial end date:
2017-07-19
Target enrollment:
Participant gender:
Summary
Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by
Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive
therapy in subjects with primary open angle glaucoma or ocular hypertension.
Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.
Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.
Patients in the period 1: In the first sequence 60 patients will be assigned to receive the
ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days
and the second sequence 60 patients will be assigned to receive the ophthalmic solution:
PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in
the period 2: the pharmacological intervention change to the opposite therapy for 30 days.