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.
Overview
- Phase
- Phase 4
- Intervention
- Dorzolamide-timolol-brimonidine and latanoprost
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in intraocular Pressure (IOP)
- Status
- Terminated
- Last Updated
- 2 years ago
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with diagnosed primary open angle glaucoma or ocular hypertension, not using a prostaglandin analogue or a β-blocker in the eye to be included in this study.
- •No treatment with any prostaglandin analogues or a β-blockers within the 30 days previous to eligibility visit, in the eye to be included in this study.
- •IOP measured with Goldmann tonometer ≥ 19 and ≤ 26 mmHg, in the eye to be included in this study.
- •Being capable of voluntarily grant a signed informed consent.
- •Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
- •Age ≥18 years old.
Exclusion Criteria
- •Pregnancy, breastfeeding or planning to become pregnant during the time of the study
- •In the case of women of childbearing age, not counting with a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- •Anterior chamber angle \< 2 in Shaffer's scale, or presence of peripheral anterior synechia, in the eye to be included in the study.
- •Being currently under treatment with any systemic ocular hypotensive drug (mannitol, glycerin, isosorbide, etc).
- •BCVA worse than 20/200, in the eye to be included in the study.
- •Serious loss of central visual field (sensibility ≤ 10 dB in ≥ 2 of the central sites), in the eye to be included in the study.
- •Having a previous history of any ophthalmological surgical or laser procedure, within the last 6 months, in the eye to be included in thee study.
- •Previous history of ocular trauma within the last 6 months, in the eye to be included in thee study.
- •Previous history of chronic uveitis, in the eye to be included in the study.
- •Previous history of intraocular, periocular, retrobulbar, subconjunctival or sub-tenon injection within the last 6 months, in the eye to be included in the study.
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
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
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))