Back to resultsNon-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK) (CONFORTK)
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRO-122
Krytantek Ofteno®
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring timolol, dorzolamide, brimonidine, Glaucoma, Ocular hypertension
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- male or female.
- obtained in the external consultation.
- With diagnosis primary of open-angle glaucoma and / or hypertension classified as mild, moderate or severe glaucomatous damage, users of Krytantek Ofteno® at least two months prior to inclusion and under control of the target IOP.
- informed consent.
Exclusion Criteria:
General Criteria
- Subjects with topical or systemic medication that interferes decisively in the results of the study. (Such as topical immunomodulators, lacrimal point tamponade, corticosteroids, ocular hypotensives other than those listed above, artificial tears with preservative).
- Subjects (female) with an active sex life who are not using a contraceptive method.
- Female Subjects in pregnancy or breastfeeding.
- Female subjects with positive urine pregnancy test.
- Positive drug addiction (verbal interrogation).
- Subjects who have participated in any clinical research study in the last 40 days.
- Legally or mentally disabled subjects to give informed consent for their participation in this study.
- Subjects who can not comply with the appointments or with all the requirements of the protocol.
Ophthalmologic criteria
- Subject with only one eye with vision.
- Subjects with visual capacity 20/200 or worse.
- Subjects with a narrow-angle history without treatment, with or without total or partial closure of the angle in either eye.
- Subjects with corneal abnormalities that prevent applanation tonometry.
- Subjects with ocular surgery or ocular trauma 6 months prior to inclusion.
- Any ocular laser surgery 3 months prior.
- Any uncontrolled or progressive retinal disease.
- Inflammatory diseases of any kind.
- Contact lens wearers.
- Subjects with a history of hypersensitivity to any of the ingredients of the research product or its analogues.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
In group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be retested and switched to a PRO-122 solution which will be used for 30 days until the 60th day, The final visit.
In group B, therapy with Krytantek Ofteno® will be suspended and changes for PRO-122 for 30 days, in which the subject will be retested and later switched to Krytantek Ofteno® solution which will be used for 30 days until the 60th day, The final visit.
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg.
The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60).
Secondary Outcome Measures
Visual Acuity (VA)
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.
Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated.
Full Information
NCT ID
NCT03257813
First Posted
August 1, 2017
Last Updated
November 20, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
1. Study Identification
Unique Protocol Identification Number
NCT03257813
Brief Title
Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)
Acronym
CONFORTK
Official Title
Clinical Study to Evaluate the Non-inferiority of PRO-122 an Ophthlamic Solution Manufactured by Laboratorios Sophia, Previous Treatment With Krytantek Ofteno ®, in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
June 18, 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-122 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus Krytantek 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 30 patients will be assigned to receive the ophthalmic solution: Krytantek Ofteno ® (timolol 0.5%%/brimonidine 0.2%/dorzolamide 2%) 1 drop B.I.D. during 30 days and the second sequence 30 patients will be assigned to receive the ophthalmic solution: PRO-122 1 drop B.I.D. during 30 days in the same period. Washout period: 20 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 timolol 0.5%/brimonidine 0.2%/dorzolamide 2% (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with PRO-122 ophthalmic solution. Patients will receive 1 drop B.I.D. into the lower conjunctival sac of either formulations and were examined at days: 1, 15, 30, 45 and 61 after initiation of treatment. A phone call security at day 75 will be performed.
Primary efficacy outcome: To evaluate the efficacy of PRO-122 versus Krytantek 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
timolol, dorzolamide, brimonidine, Glaucoma, Ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
60 subjects with diagnosis of open angle primary glaucoma with mild, moderate or severe damage and / or with intraocular hypertension users of Krytantek Ofteno® at least two previous months and are under control Of the corresponding IOP target.
a study group A or B will be randomly assigned, in group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be evaluated again and switched from therapy to solution PRO-122 which will be used for 30 days until the 60th day, date of the final visit.
In the case of those assigned to group B on day 1, the change to PRO-122 solution will be made for 30 continuous days until the date of revision on day 30, the day on which treatment with Krytantek Ofteno® will be restored to continue until the Day 60 for the final evaluation.
The selected subjects will be observed for 60 days.
Masking
ParticipantInvestigator
Masking Description
Masking will be carried out using identical boxes in the primary package in both groups.
Blinding for the research subject and the investigator will be carried out by using labels containing the assignation number, which will replace the original labels in the case of the comparator. Due to the nature of the primary containers of the research products, single-dose vials and multidose bottle, it is not possible to use identical labels.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
In group A, therapy with Krytantek Ofteno® will be continued for 30 days, in which the subject will be retested and switched to a PRO-122 solution which will be used for 30 days until the 60th day, The final visit.
Arm Title
Group B
Arm Type
Other
Arm Description
In group B, therapy with Krytantek Ofteno® will be suspended and changes for PRO-122 for 30 days, in which the subject will be retested and later switched to Krytantek Ofteno® solution which will be used for 30 days until the 60th day, The final visit.
Intervention Type
Drug
Intervention Name(s)
PRO-122
Other Intervention Name(s)
timolol, dorzolamide, brimonidine
Intervention Description
1 drop every 12 hours for 30 days of alternating treatment with 30 days
Intervention Type
Drug
Intervention Name(s)
Krytantek Ofteno®
Other Intervention Name(s)
timolol, dorzolamide, brimonidine
Intervention Description
1 drop every 12 hours for 30 days of alternating treatment with 30 days
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg.
The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60).
Time Frame
Change from Baseline intraocular pressure at day 30 and 60.
Secondary Outcome Measure Information:
Title
Visual Acuity (VA)
Description
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.
Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated.
Time Frame
Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
The presence of adverse events by percentage between groups will be evaluated. the scale is present or absent.
Time Frame
75 days, includes the security call
Title
Conjunctival Hyperemia
Description
the conjunctival hyperemia will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
Time Frame
Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Title
Chemosis
Description
Chemosis: qualitative ordinal variable, will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.
Time Frame
Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Title
Eye Burning
Description
Eye ocular burning will be evaluated by the presence or absence of it and the number of affected by group will be reported.
Time Frame
Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Title
Number of Eyes With Tearing
Description
Tearing will be evaluated by the presence or absence of it and the number of affected by group will be reported
Time Frame
Baseline (day 1) crossover visit (day 30) and final visit (day 60)
Title
Number of Eyes With Foreign Body Sensation
Description
Foreign body sensation will be evaluated by the presence or absence of it and the number of affected by group will be reported.
Time Frame
Baseline (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:
18 years of age or older
male or female.
obtained in the external consultation.
With diagnosis primary of open-angle glaucoma and / or hypertension classified as mild, moderate or severe glaucomatous damage, users of Krytantek Ofteno® at least two months prior to inclusion and under control of the target IOP.
informed consent.
Exclusion Criteria:
General Criteria
Subjects with topical or systemic medication that interferes decisively in the results of the study. (Such as topical immunomodulators, lacrimal point tamponade, corticosteroids, ocular hypotensives other than those listed above, artificial tears with preservative).
Subjects (female) with an active sex life who are not using a contraceptive method.
Female Subjects in pregnancy or breastfeeding.
Female subjects with positive urine pregnancy test.
Positive drug addiction (verbal interrogation).
Subjects who have participated in any clinical research study in the last 40 days.
Legally or mentally disabled subjects to give informed consent for their participation in this study.
Subjects who can not comply with the appointments or with all the requirements of the protocol.
Ophthalmologic criteria
Subject with only one eye with vision.
Subjects with visual capacity 20/200 or worse.
Subjects with a narrow-angle history without treatment, with or without total or partial closure of the angle in either eye.
Subjects with corneal abnormalities that prevent applanation tonometry.
Subjects with ocular surgery or ocular trauma 6 months prior to inclusion.
Any ocular laser surgery 3 months prior.
Any uncontrolled or progressive retinal disease.
Inflammatory diseases of any kind.
Contact lens wearers.
Subjects with a history of hypersensitivity to any of the ingredients of the research product or its analogues.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Confidentiality Policy
Citations:
PubMed Identifier
29680880
Citation
Gomez-Aguayo F, Paczka JA, Lenero-Cordova R, Jimenez-Roman J, Davila-Villarreal J, Hartleben C, Baiza-Duran L, Olvera-Montano O, Garcia-Velez F, Munoz-Villegas P. A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma. Ophthalmol Ther. 2018 Jun;7(1):145-156. doi: 10.1007/s40123-018-0128-8. Epub 2018 Apr 21.
Results Reference
derived
Learn more about this trial
Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)
We'll reach out to this number within 24 hrs