Clinical trial NCT02801617: Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Official title: A Multicentric, Prospective, Crossover, Double Blind Clinical Study to Evaluate the Non-inferiority of PRO-067 an Ophthlamic Solution Manufactured by Laboratorios Sophia S.A.de C.V., Previous Treatment With GAAP Ofteno ®, in Subjects With Primary Open-angle Glaucoma (POAG) or Ocular Hypertension (OHT): COMPLIANCE Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Latanoprost
Glaucoma
Ocular hypertension
Crossover study
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The American Academy of Ophthalmology Glaucoma Panel The primary open angle glaucoma (POAG) is a progressive, chronic optic neuropathy in adults in which intraocular pressure (IOP) and other currently unknown factors contribute to damage and in which, in the absence of other identifiable causes, there is a characteristic acquired atrophy of the optic nerve and loss of retinal ganglion cells and their axons. This condition is associated with an anterior chamber angle that is open by gonioscopic appearance.

This is a multicentric, crossover, double blind and prospective clinical study. The investigators will include patients with confirmed diagnosis of primary open-angle glaucoma or ocular hypertension, with target intraocular pressure (TIOP) within a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.

Patients will be randomly divided into 2 groups, one of them treated with a known formulation of Latanoprost 0.005% (GAAP Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with PRO-067 ophthalmic solution. Patients will receive 1 drop per day (QD) into the lower conjunctival sac of either formulations and were examined at days: 1, 15, 30, 45 ad 60 after initiation of treatment. A phone call security at day 75 will be performed.

Primary efficacy outcome: To evaluate the efficacy of PRO-067 versus GAAP Ofteno ® instilled onto the ocular surface in subjects with primary open angle glaucoma (POAG) or ocular hypertension (HTO), to control and maintenance of the target intraocular pressure (TIOP).

Eligibility 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

Primary outcomes:
measure: Target Intraocular Pressure (TIOP)
timeFrame: the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences
measure: Number of Adverse Events.
timeFrame: it is evaluated from the baseline visit (day 1) to the security call (day 75)
Secondary outcomes:
measure: Percentage of Ocular Burning
timeFrame: at the basal visit (day 1) crossover visit (day 30) and final visit (day 60)
measure: Percentage of Participants With Foreign Body Sensation
timeFrame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
measure: Percentage of Participants With Tearing
timeFrame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
measure: Percentage of Participants With Chemosis
timeFrame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
measure: Percentage of Participants With Hyperemia
timeFrame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
Other outcomes:
Locations:
city: Zapopan
country: Mexico
facility: Contract Research Organization
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References: