Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When Applied on the Ocular Surface of Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Naphazoline / Hypromellose Ophthalmic
- Conditions
- Hyperemia Eye
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP) Increment
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
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.
Investigators
Eligibility 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.
Arms & Interventions
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.
Intervention: Naphazoline / Hypromellose Ophthalmic
Outcomes
Primary Outcomes
Intraocular Pressure (IOP) Increment
Time Frame: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Heart Rate Increment
Time Frame: 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 (Systolic)
Time Frame: 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
Time Frame: Trough Day 10 (+1)
Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.
Incidence of Pharmacological Mydriasis
Time Frame: Trough Day 10 (+1)
Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.
Blood Pressure Increment (Diastolic)
Time Frame: 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.