Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap … (NCT04702789) | Clinical Trial Compass
TerminatedPhase 4
Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.
Stopped: For interests of sponsor.
Mexico28 participantsStarted 2021-10-19
Plain-language summary
Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with primary open-angle glaucoma (according to the Preferred Practice Pattern guidelines of the American Academy of Ophthalmology) or ocular hypertension, not controlled by a prostaglandin analogue or a β-blocker in the eye to be included in the study.
* Previous treatment for at least 30 days prior to the eligibility visit with a prostaglandin analogue or a β-blocker in the eye to be included in the study.
* Intraocular pressure measured by Goldmann tonometry ≥ 19 and ≤ 26 mmHg in the eye to be included in the study.
* Ability to voluntarily provide informed consent.
* Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
* Age ≥ 18 years.
Exclusion Criteria:
* Pregnant, breastfeeding, or planning to become pregnant during the clinical study.
* For women of reproductive age, not using a hormonal contraceptive method, intrauterine device, or bilateral tubal ligation.
* Anterior chamber angle \< 2 in the Shaffer Classification or presence of peripheral anterior synechiae in the eye to be included in the study.
* Currently undergoing treatment with any systemic ocular hypotensive agent (e.g., mannitol, glycerin, isosorbide).
* Best Corrected Visual Acuity worse than 20/200 in the eye to be included in the study.
* Severe central visual field loss (sensitivity ≤ 10 dB in ≥ 2 of the 4 central points of the visual field fixation point) in the eye to be included in the study.
* History of ocular surger…