Status:
UNKNOWN
Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
Device Description - A combination of punctual plug (new product) as delivery system for Latanoprost (already approved drug). The plug has 2 different sizes of "big plug" (450 µg API) and "small plug"...
Eligibility Criteria
Inclusion
- 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
- 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
- Indication of optic nerve damage and visual function deterioration according to the investigator's judgment
- Lower lacrimal Punctum (tear duct) diameter is smaller than 0.4mm or greater than or equal to 0.75mm
- Pregnancy or lactation (questioned by the consenting investigator), unwillingness to avoid pregnancy
- Use of (topical or systemic) corticosteroids within 2 months before enrolment. Any systemic condition or medication that can affect IOP.
- Known intolerance to PGA eye drops
- Use of oral IOP-lowering medication
- Punctual occlusions or other anatomic abnormality
- Previous incisional ocular surgery (e.g., conventional filtering surgery) to lower IOP
- Evidence of current or prior angle closure
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03318146
Start Date
June 1 2018
End Date
September 1 2019
Last Update
November 28 2017
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102