Safety and Tolerability of PRO-185
Study Details
Study Description
Brief Summary
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRO-185 Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days. |
Drug: Naphazoline / Hypromellose Ophthalmic
Naphazoline 0.03% / Hypromellose 0.2%
|
Outcome Measures
Primary Outcome Measures
- Intraocular pressure increment [Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)]
Safety evaluation through the incidence of subjects presenting an elevation > 5 mmHg in intraocular pressure 20 minutes after administration, in comparison to baseline value.
- Heart rate increment [Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)]
Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
- Blood pressure increment [Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)]
Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
- Incidence of Conjunctival Hyperemia [Trough Day 10 (+1)]
Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale).
- Incidence of Pharmacological Mydriasis [Trough Day 10 (+1)]
Tolerability evaluation through the incidence of pharmacological mydriasis measured through OPD III scan (considered as a difference > 2 mm compared to the baseline value).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Being clinically healthy
-
Having the ability to grant a signed informed consent
-
Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
-
Age between 18 and 45 years
-
Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
-
Best corrected visual acuity equal of better than 20/30 in both eyes.
-
Vital signs within normal ranges.
-
Intraocular pressure ≥10 and ≤ 21 mmHg
Exclusion Criteria:
-
Using any kind of topic ophthalmic products
-
Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
-
History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
-
History of iridotomies or waiting for this procedure to take place.
-
Conjunctival hyperemia grade 3 or 4 according to Efron scale.
-
Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
-
Using medications or herbology products, through any route of administration.
-
Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
-
Previous participation in any clinical study 90 days prior to the inclusion in the present study.
-
Previous participation in this study.
-
Using contact lenses which cannot be suspended during the period of this study.
-
History of any chronic illness, including diabetes and hypertension.
-
Active inflammation or infection at the time of inclusion in this study.
-
Unresolved lesions or traumas at the moment of inclusion in this study.
-
History of any kind of ocular surgery.
-
History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Laboratorios Sophia S.A de C.V.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOPH185-0521/I