This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.
The variables to be evaluated include: Primary (safety): \- Incidence of unexpected advere events (AE's) Secondary: * Changes in the ocular comfort index (OCI) score * Changes in intraocular pressure (IOP) * Changes in Best Corrected Visual Acuity (BCVA) * Adherence to treatment * Changes in tear film breakup time * Changes in fluorescein staining * Changes in lissamine green staining
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Incidence of unexpected adverse events related to the interventions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Time frame: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)
Changes in the Ocular Comfort Index score
Changes in the Ocular Comfort Index (OCI) score in between interventions, the subjects will be questioned regarding this symptoms' incidence. The OCI contains 8 items (one positive and eight negative) that focus on discomfort associated with ocular surface disorders. Each of these questions has two parts, which separately inquire about the frequency and severity of symptoms. The OCI score will be used for evaluation of tolerability through incidence and severity of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Time frame: Days: 0 (Basal Visit), and 8 (Final Visit)
Adherence to treatment (adherence) Adherence to treatment (adherence)
Adherence will be evaluated through the treatment record in the subject's diary.
Time frame: Days: 8 (Final Visit)
Changes in Best Corrected Visual Acuity (BCVA)
The BCVA will be evaluated through Snellen chart.
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)
Changes in tear film breakup time
The most common method for assessing stability is with fluorescein. The precorneal layer colored with fluorescein will change to less fluorescent or non-fluorescent regions. The time from the last blink to the appearance of these regions is the tear film breakup time.
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)
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Changes in intraocular pressure (IOP)
Previous instillation of topical anesthetic, the IOP will be measured through a Goldmann tonometer during visits
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)
Changes in the integrity of the ocular surface (fluorescein staining)
Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)
Changes in lissamine green staining of the conjunctival surface
Direct observation with slit lamp, graded according to (changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance \[SICCA\].)
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit)