Overview

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:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Treatments:
Latanoprost
Ophthalmic Solutions
Criteria
Inclusion Criteria:

- Female or male

- Age: ≥18 years old

- Patients with primary open angle glaucoma with mild to moderate damage or ocular
hypertension that were sufficiently controlled with GAAP Ofteno® (latanoprost 0.005%)
within the last 60 days

- Signed Informed Consent Form

Exclusion Criteria:

- Subjects with unique eye

- Subjects with visual acuity < 20/200

- Another kind of glaucoma disease different to primary open angle glaucoma

- corneal disturbances with impossibility to measure the intraocular pressure

- retinal alterations without control or progressive retinal disease with high risk to
lost vision