Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

Sponsor

Sylentis, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01739244

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of SYL040012 in subjects with ocular hypertension or open-angle glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open Angle Glaucoma	Drug: SYL040012 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYL040012 eye drops dose A Ocular topical administration of SYL040012 eye drops dose A	Drug: SYL040012 Ocular topical administration of SYL040012 for 14 consecutive days
Experimental: SYL040012 eye drops dose B Ocular topical administration of SYL040012 eye drops dose B	Drug: SYL040012 Ocular topical administration of SYL040012 for 14 consecutive days
Experimental: SYL040012 eye drops dose C Ocular topical administration of SYL040012 eye drops dose C	Drug: SYL040012 Ocular topical administration of SYL040012 for 14 consecutive days
Placebo Comparator: Placebo Ocular topical administration of placebo eye drops	Drug: Placebo Ocular topical administration of placebo for 14 consecutive days

Outcome Measures

Primary Outcome Measures

Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period [14 days + (4-7 days)]
Simple Corneal and Conjunctival Evaluation [15 days + (3-6 days)]

Secondary Outcome Measures

Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability. [14 days + (4-7 days)]
Physical exploration and laboratory tests as measurements of general tolerability [14 days + (4-7 days)]
Assessment of Adverse Events Appearance [14 days + (4-7 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must provide signed informed consent prior to participation in any study-related procedures.
Male and female subjects in good or fair general health as assessed by the investigator.
≥18 years of age.
Previous history or newly diagnosed elevated IOP (≥21 mmHg) with or without open-angle glaucoma in both eyes.
Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writing within the last 3 months prior to baseline period i.e. up to 4 months before Day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination:
Visual field 24-2 or equivalent
Optical coherence tomography (OCT)
Best corrected visual acuity ≥0.5 (20/40) on the Snellen chart, or ≤ 0.3 logMAR
Schirmer test (lacrimation)
Funduscopy

Exclusion Criteria:

Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study.
Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit.
Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function.
Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
Body temperature.
Intolerability of any components of SYL040012 or placebo.
Unable to comply with the clinical trial requirements as judged by the investigator.
Beta blockers or corticosteroids use (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration
Previous refractive surgery; cataract extraction in the last 6 months
Previous surgery for glaucoma.
Participation in a clinical trial within 2 months before the enrolment visit
Use of any other investigational product within 60 days before the enrolment visit.
Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study.
Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial
History of ocular infection or inflammation within the last 3 months before the enrolment visit
Angle-closure or pigmentary glaucoma.
Chronic or current acute eye diseases such as scleritis, uveitis, blepharitis, conjunctivitis, or ocular Herpes simplex virus infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Tallin Central Hospital	Tallin		Estonia	10138
2	Eye Clinic Dr. Krista Turman	Tallin		Estonia	13419
3	Universitaetsklinikum Freiburg	Freiburg		Germany	79106
4	Uniklinik Köln	Köln		Germany	50937
5	Universitaetsklinikum Mainz	Mainz		Germany	55131
6	Clinica Universidad Navarra	Pamplona	Navarra	Spain	31008
7	Institut Català de Retina	Barcelona		Spain	08022
8	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
9	Hospital Universitario Clínico San Carlos	Madrid		Spain	28040
10	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
11	Instituto de Oftalmobiología Aplicada	Valladolid		Spain	47011