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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801617
Recruitment Status : Terminated (expiration time limit of recruitment)
First Posted : June 16, 2016
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE June 16, 2016
Results First Submitted Date  ICMJE February 1, 2018
Results First Posted Date  ICMJE October 28, 2019
Last Update Posted Date October 28, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • Target Intraocular Pressure (TIOP) [ Time Frame: the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences ]
    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. [ Time Frame: it is evaluated from the baseline visit (day 1) to the security call (day 75) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
  • Target Intraocular Pressure [ Time Frame: 30 days ]
    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 + 2mmHg
  • Safety assessed by number of study subjects with adverse events. [ Time Frame: 30 days ]
    Examination of: visual acuity best corrected, biomicroscopy for the anterior segment, fundus examination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
  • Percentage of Ocular Burning [ Time Frame: at the basal visit (day 1) crossover visit (day 30) and final visit (day 60) ]
    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 [ Time Frame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60) ]
    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 [ Time Frame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60) ]
    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 [ Time Frame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60) ]
    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 [ Time Frame: basal visit (day 1), Crossover visit (day 30) and final visit (day 60) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
Tolerability assessed by number of study subjects with signs and symptoms [ Time Frame: 30 days ]
Ocular burning, bulbar conjunctival hyperemia, foreign body sensation, tearing, fluorescein staining, ocular surface disease index score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PRO-067
    1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.
    Other Name: SOPH067-0914/III
  • Drug: GAAP Ofteno®
    1 drop QD during 30 days Active comparator, reference medication.
    Other Name: Latanoprost 0.005% , prostaglandin, antiglaucoma medication
Study Arms  ICMJE
  • Experimental: Sequence 1 (PRO-067)

    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

    Interventions:
    • Drug: PRO-067
    • Drug: GAAP Ofteno®
  • Active Comparator: Sequence 2 (GAAP Ofteno®)

    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

    Interventions:
    • Drug: PRO-067
    • Drug: GAAP Ofteno®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
116
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2016)
100
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date March 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801617
Other Study ID Numbers  ICMJE SOPH067-0914/III
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Electronic Case Report Format (eCRF). The on line registry in a digital platform will help to verification process.
Responsible Party Laboratorios Sophia S.A de C.V.
Study Sponsor  ICMJE Laboratorios Sophia S.A de C.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leopoldo Baiza Durán, MD Laboratorios Sophia S.A de C.V.
PRS Account Laboratorios Sophia S.A de C.V.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP