Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension

NCT02801617 | Terminated Phase 3 Results DMC

• 1 other identifier: SOPH067-0914/III
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Latanoprost; Glaucoma; Ocular hypertension; Crossover study

Outcome Measures

Primary Outcomes (2)

• Target Intraocular Pressure (TIOP)

  Target Intraocular Pressure (TIOP): Efficacy of experimental drug or active comparator to maintain the IOP in 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.The upper limit of intraocular pressure is: TIOP + 2 mmHg. The measurement of the TIOP in each treatment period.

  the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences

• Number of Adverse Events.

  the two periods of PRO-067 of each sequence were grouped as well as those of GAAP to form two comparative groups of adverse events in each intervention. (PRO-067 vs. GAAP ofteno). The number of adverse events presented throughout the study was evaluated with each study drug to make the comparison between groups.

  it is evaluated from the baseline visit (day 1) to the security call (day 75)

Secondary Outcomes (5)

• Percentage of Ocular Burning

  at the basal visit (day 1) crossover visit (day 30) and final visit (day 60)

• Percentage of Participants With Foreign Body Sensation

  basal visit (day 1), Crossover visit (day 30) and final visit (day 60)

• Percentage of Participants With Tearing

  basal visit (day 1), Crossover visit (day 30) and final visit (day 60)

• Percentage of Participants With Chemosis

  basal visit (day 1), Crossover visit (day 30) and final visit (day 60)

• Percentage of Participants With Hyperemia

  basal visit (day 1), Crossover visit (day 30) and final visit (day 60)

Study Arms (2)

Sequence 1 (PRO-067)

EXPERIMENTAL

study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours

Drug: PRO-067; Drug: GAAP Ofteno®

Sequence 2 (GAAP Ofteno®)

ACTIVE COMPARATOR

study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours

Drug: PRO-067; Drug: GAAP Ofteno®

Interventions

PRO-067 DRUG

1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.

Also known as: SOPH067-0914/III

Sequence 1 (PRO-067); Sequence 2 (GAAP Ofteno®)

GAAP Ofteno® DRUG

1 drop QD during 30 days Active comparator, reference medication.

Also known as: Latanoprost 0.005% , prostaglandin, antiglaucoma medication

Sequence 1 (PRO-067); Sequence 2 (GAAP Ofteno®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

Contract Research Organization

Zapopan, Jalisco, 45010, Mexico

Location

Related Links

• Mexican Registry of Clinical trials. The Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

Latanoprost; Prostaglandins

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

The limitations of this study were its short duration (60 days) and the size of the groups that was reduced.

Results Point of Contact

• Title: Dr. Oscar Olvera
• Organization: Laboratorios Sophia

oscar.olvera@sophia.com.mx

(33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: September 1, 2015
• Primary Completion: March 15, 2017
• Study Completion: July 19, 2017
• Last Updated: July 5, 2024
• Results First Posted: October 28, 2019

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)