Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP (NCT03318146) | Clinical Trial Compass
UnknownNot Applicable
Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP
Israel40 participantsStarted 2018-06-01
Plain-language summary
Glaucoma is the most frequent cause of irreversible \& preventable blindness worldwide, affecting about 2% of the world's population in people over 40. The major risk factor, and only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can slow or arrest the progression of vision loss.
Current treatment consists of drops administered on a daily basis with unfortunately low patient compliance, increasing the chance of blindness.
Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus solves the significant problem of patient compliance.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 18-80 years consecutive males or females diagnosed with open angle early visual field defects glaucoma or ocular hypertension in both eyes and treated with eye drop medications .
✓. Treated IOP lower than 26 mmHg on at least 2 consecutive examinations.
✓. If glaucoma, mean deviation must be better than -10 mmHg in study eye (early visual field defects glaucoma)
✓. IOP increase of at least 3 mmHg from start of washout in both eyes.
Exclusion criteria
✕. Any record of IOP ever being higher than 33 mmHg.
✕. Corneal or other anatomical abnormalities preventing reliable applanation tonometry
✕. Severe dry eye,
✕. Use of contact lenses
✕. Intolerance or contraindication to latanoprost or BAK
✕0. Indication of optic nerve damage and visual function deterioration according to the investigator's judgment
What they're measuring
1
Safety Endpoint - the incidence of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Timeframe: Will be evaluated through study completion (3 months)