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