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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Terminated
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
PRO-067
GAAP Ofteno®
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Latanoprost, Glaucoma, Ocular hypertension, Crossover study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contract Research Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequence 1 (PRO-067)

Sequence 2 (GAAP Ofteno®)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Ocular Burning
the ocular burning of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as present or absent, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Percentage of Participants With Foreign Body Sensation
The foreign body sensation will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Percentage of Participants With Tearing
The tearing will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Percentage of Participants With Chemosis
The chemosis will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Percentage of Participants With Hyperemia
the hyperemia of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as a scale of: absent, very mild, mild, moderate and severe, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.

Full Information

First Posted
June 13, 2016
Last Updated
October 3, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02801617
Brief Title
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Acronym
COMPLIANCE
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
expiration time limit of recruitment
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
Latanoprost, Glaucoma, Ocular hypertension, Crossover study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1 (PRO-067)
Arm Type
Experimental
Arm Description
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
Arm Title
Sequence 2 (GAAP Ofteno®)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PRO-067
Other Intervention Name(s)
SOPH067-0914/III
Intervention Description
1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.
Intervention Type
Drug
Intervention Name(s)
GAAP Ofteno®
Other Intervention Name(s)
Latanoprost 0.005% , prostaglandin, antiglaucoma medication
Intervention Description
1 drop QD during 30 days Active comparator, reference medication.
Primary Outcome Measure Information:
Title
Target Intraocular Pressure (TIOP)
Description
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.
Time Frame
the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences
Title
Number of Adverse Events.
Description
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.
Time Frame
it is evaluated from the baseline visit (day 1) to the security call (day 75)
Secondary Outcome Measure Information:
Title
Percentage of Ocular Burning
Description
the ocular burning of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as present or absent, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Time Frame
at the basal visit (day 1) crossover visit (day 30) and final visit (day 60)
Title
Percentage of Participants With Foreign Body Sensation
Description
The foreign body sensation will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Time Frame
basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
Title
Percentage of Participants With Tearing
Description
The tearing will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Time Frame
basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
Title
Percentage of Participants With Chemosis
Description
The chemosis will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Time Frame
basal visit (day 1), Crossover visit (day 30) and final visit (day 60)
Title
Percentage of Participants With Hyperemia
Description
the hyperemia of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as a scale of: absent, very mild, mild, moderate and severe, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.
Time Frame
basal visit (day 1), Crossover visit (day 30) and final visit (day 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Baiza Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Contract Research Organization
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45010
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Electronic Case Report Format (eCRF). The on line registry in a digital platform will help to verification process.
Links:
URL
http://189.254.115.250/Resoluciones/Consultas/ConWebRegEnsayosClinicosDetalle.asp?idsolicitud=2036
Description
Mexican Registry of Clinical trials. The Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

Learn more about this trial

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

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