This is a double-blind, randomized, vehicle controlled, two-way crossover repeated administration study performed in presbyopic subjects.
- Conditions
- Presbyopia is part of the natural ageing process of the eye. It is usually noticed at around the age of 40 years. The main symptom of this condition is a progressive blurring of vision when performing near tasks such as reading, sewing, working at a computer, using a tablet mobile phone etc. The individual may complain of headaches and become more reliant on better illumination when attempting to see fine detail close up.Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
- Registration Number
- EUCTR2016-001091-30-SI
- Lead Sponsor
- ORASIS Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 37
Men and women between 40 and 65 years of age (inclusive)
Subjects who provide written informed consent to participate in the study
Subjects have signs of presbyopia upon ophthalmic examination
Subjects have normal presbyopia with low distance refraction (sphere no greater than ±0.75 Dioptres cylinder no greater than ± 0.75DC, refraction along any principal meridian no greater than 1.00 Dioptres)
Subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is > +1.00 Dioptres
Subjects in general good health in the opinion of the Investigator as determined by medical history
Women with childbearing potential must have a negative urine pregnancy test at Screening and be willing and able to use a medically acceptable method of birth control or postmenopausal.
Acceptable methods of birth control in this study include: vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device (IUD), hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam).
Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of macular disease or any other ocular conditions or congenital malformation
Any medical condition known to affect the structure of uvea, cornea, lens or retina or main function of the eyes
No cataract or minimal nuclear sclerosis
Severe dry eye
Any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before the Screening visit
Contact lenses for the past three months before the Screening visit
A difference of more than 0.50 Dioptres between the manifest spherical equivalent and the wavefront refraction spherical equivalent Pupil size less than 2,5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the Baseline visit
A history of herpes (of any kind) in either eye
Cataract surgery and/or refractive surgery in either eye
Known contraindication, hypersensitivity and/or allergy to any study drugs or excipients
Any acute illness (e.g. acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator
Participation in another clinical trial with drugs received within 30 days of Screening
Pregnant or currently lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary <br>To establish safety and tolerability of repeated administration of PresbiDrops in presbyopic subjects<br>;Secondary Objective: Secondary<br>To determine the efficacy of repeated administration of PresbiDrops in presbyopic subjects<br>;Primary end point(s): Primary Efficacy Endpoint:<br>At least a 2 lines improvement from Baseline in uncorrected intermediate and near visual acuity (monocular and binocular)<br>;Timepoint(s) of evaluation of this end point: The maximum treatment duration is 28 days (14 days drug, 14 days placebo)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Endpoint:<br>Change from Baseline of the depth of focus at distance and near<br>Change from Baseline in uncorrected distance visual acuity (monocular and binocular)<br>Change from Baseline in spectacle independency (reported by the subjects in structured study questionnaire)<br>Change from Baseline in pupil diameter and appearance<br>Change from Baseline of stability of tear film<br>Change from Baseline of visual field test results<br>Change from Baseline of the ocular 3rd 4th and 5th higher order aberrations (spherical aberration, trefoil and coma);Timepoint(s) of evaluation of this end point: 64 days (~9 weeks)