Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in intraocular Pressure (IOP)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
After signing the informed consent form (ICF), every subject will receive a coded patient number. Randomization will take place through and integrated web response system (IWRS). In the first step, during the eligibility visit, all patients will be assigned the same treatment (Gaap Ofteno PF®). After one month, patients that once again comply with the inclusion criteria will be assigned randomly (1:1) to one of the two investigation products, either Krytantek Ofteno PF® or Eliptic Ofteno PF®.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 surgery or laser eye procedure in the last 6 months in the eye to be included in the study.
- •History of ocular trauma in the last 6 months in the eye to be included in the study.
- •History of chronic uveitis in the eye to be included in the study.
- •History of intraocular, periocular, retrobulbar, subconjunctival, or subtenon injection in the last 6 months in the eye to be included in the study.
- •Patients with silicone, or who have had silicone in the anterior or posterior segment of the eye to be included in the study.
- •Diagnosis of aphakia in the eye to be included in the study.
- •Any corneal abnormality that decreases the reliability of Goldmann tonometry in the eye to be included in the study.
- •Known hypersensitivity to the active ingredients used in the study (prostaglandin analogues, β-adrenergic blockers, α2-adrenergic agonists, carbonic anhydrase inhibitors).
- •Diseases that contraindicate the use of the active ingredients used in the study (e.g., severe asthma or COPD, 2nd or 3rd degree atrioventricular block not controlled by a pacemaker, sinus bradycardia, manifest heart failure, Chronic Kidney - - Disease with a CrCl < 30 ml/min).
- •Patients requiring the use of monoamine oxidase inhibitors (MAOIs), and patients treated with antidepressants affecting noradrenergic transmission (e.g., tricyclic antidepressants and mianserin).
- •Patients who use, or have used in the last month, topical ocular steroids in the eye to be included in the study, or steroids via oral, intravenous, intramuscular, dermal, or intralesional routes.
- •Have participated in another clinical research study within 30 days prior to signing the informed consent form (ICF).
- •Have previously participated in this study.
- •Have a history of drug addiction within the last two years prior to signing the ICF.
- •Have any type of surgical intervention planned during the study period.
- •Be or have an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is part of the research site personnel or the sponsor
Arms & Interventions
Arm 1; Dorzolamide-timolol-brimonidine and latanoprost; Krytantek Ofteno PF® and Gaap Ofteno PF®
Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Krytantek Ofteno® (dorzolamide 2%, timolol 0.5% and brimonidine 0.2%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days).
Intervention: Dorzolamide-timolol-brimonidine and latanoprost (Drug)
Arm 2; Dorzolamide-timolol and latanoprost; Eliptic Ofteno PF® and Gaap Ofteno PF®
Application of Gaap Ofteno® (latanoprost 0.005%; preservative free) ophthalmic solution every 24 hours at 21:30 hours (± 15 min) for the duration of the study (total exposure: 90 days). One month after initiating Gaap Ofteno® instillation, application of Eliptic Ofteno® (dorzolamide 2% and timolol 0.5%; preservative free) ophthalmic solution will be added every 12 hours at 9:00 and 21:00 hours (± 10 min) (total exposure: 60 days).
Intervention: Dorzolamide-timolol and latanoprost (Drug)
Outcomes
Primary Outcomes
Change in intraocular Pressure (IOP)
Time Frame: Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit)
Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated at 9:00 and at 11:00 hrs. (± 30 minutes). Both measurements and their average will be registered. Normal values are considered between 10 and 21 mmHg.
Secondary Outcomes
- Change in optic nerve image(Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit))
- Change in nerve fibers and ganglion cell thickness(Days: 0 (basal visit) and 60 (± 2) (final visit))
- Change in central corneal thickness(Days: 0 (basal visit) and 60 (± 2) (final visit))
- Change in Best Corrected Visual Acuity (BCVA)(Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit))
- Changes in optic nerve cup/disc ratio(Days: -30 (± 2) (eligibility visit), 0 (basal visit) and 60 (± 2) (final visit))
- Change in ocular surface integrity (conjunctival hyperemia, chemosis, and corneal fluorescein staining)(Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit))
- Incidence of adverse events(Day: 75 (± 3) (safety call))
- Changes in Ocular Comfort Index(Days: -30 (± 2) (eligibility visit), 0 (basal visit), 14 (± 2) (first follow-up visit), 30 (± 2) (second follow-up visit) and 60 (± 2) (final visit))
- Change in visual fields(Days: 0 (basal visit) and 60 (± 2) (final visit))