Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Latanoprost; Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. 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 .

2. Treated IOP lower than 26 mmHg on at least 2 consecutive examinations.

3. If glaucoma, mean deviation must be better than -10 mmHg in study eye (early visual field defects glaucoma)

4. IOP increase of at least 3 mmHg from start of washout in both eyes.

Exclusion Criteria:

5. Any record of IOP ever being higher than 33 mmHg.

6. Corneal or other anatomical abnormalities preventing reliable applanation tonometry

7. Severe dry eye,

8. Use of contact lenses

9. Intolerance or contraindication to latanoprost or BAK

10. Indication of optic nerve damage and visual function deterioration according to the investigator's judgment

11. Lower lacrimal Punctum (tear duct) diameter is smaller than 0.4mm or greater than or equal to 0.75mm

12. Pregnancy or lactation (questioned by the consenting investigator), unwillingness to avoid pregnancy

13. Use of (topical or systemic) corticosteroids within 2 months before enrolment. Any systemic condition or medication that can affect IOP.

14. Known intolerance to PGA eye drops

15. Use of oral IOP-lowering medication

16. Punctual occlusions or other anatomic abnormality

17. Previous incisional ocular surgery (e.g., conventional filtering surgery) to lower IOP

18. Evidence of current or prior angle closure