Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Sophia S.A de C.V.
About this trial
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®.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Having the ability to voluntarily give their signed informed consent.
Ophthalmologically and clinically healthy subjects.
Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
Age ≥18 years.
Disqualifiers
History of hypersensitivity to any of the components of the drugs under investigation.
Use of ophthalmic medications from any pharmacological group.
Use of medications by any other route of administration.
Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
Trial design
Design model
Parallel
Treatments tested in this trial
PRO-240
Drug-Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.
Optive®
Drug\- Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: PRO-240Experimental treatment 1 intervention
Group B: Optive®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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