Status:
COMPLETED
Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)
Lead Sponsor:
Laboratorios Sophia S.A de C.V.
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sub...
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 currentl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03257813
Start Date
April 1 2016
End Date
June 18 2017
Last Update
December 9 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.