Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)

NCT03257813 | Completed Phase 3 Results DMC

• 1 other identifier: SOPH122-0914/III
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

timolol; dorzolamide; brimonidine; Glaucoma; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from Baseline intraocular pressure at day 30 and 60.

Secondary Outcomes (1)

• Visual Acuity (VA)

  Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)

Other Outcomes (6)

• Adverse Events

  75 days, includes the security call

• Conjunctival Hyperemia

  Baseline (day 1) crossover visit (day 30) and final visit (day 60)

• Chemosis

  Baseline (day 1) crossover visit (day 30) and final visit (day 60)

Study Arms (2)

Group A

OTHER

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.

Drug: PRO-122; Drug: Krytantek Ofteno®

Group B

OTHER

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.

Drug: PRO-122; Drug: Krytantek Ofteno®

Interventions

PRO-122 DRUG

1 drop every 12 hours for 30 days of alternating treatment with 30 days

Also known as: timolol, dorzolamide, brimonidine

Group A; Group B

Krytantek Ofteno® DRUG

1 drop every 12 hours for 30 days of alternating treatment with 30 days

Also known as: timolol, dorzolamide, brimonidine

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• years of age or older
• male or female.
• obtained in the external consultation.
• informed consent.

You may not qualify if:

• 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.
• Any ocular laser surgery 3 months prior.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 29680880 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

Timolol; dorzolamide; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Ricardo Llamas (clinical safety pharmacologist)
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

3001 4200

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
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 22, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 18, 2017
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share