EXP-LP is a novel and innovative drug delivery system aiming to improve patient compliance and outcomes. EXP-LP punctum plug, is a non-invasive insert that replaces eye drops and provides sustained therapy for glaucoma, dry eye and other major eye diseases. EXP-LP is a combination of an ophthalmic prostaglandin drug (Latanoprost). The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye

XALATAN® (latanoprost ophthalmic solution) is an eye drop used to treat high eye pressure/intraocular pressure in people with open-angle glaucoma or ocular hypertension. XALATAN is administrated once a day

Glaucoma

Ocular Hypertension

The EXP-LP sustained released formula inserted into a small punctual plug. The plug is designed to release the drug over a period of up to 6 months in a slow release profile.

drug delivery system

one drop in the affected eye(s) once daily in the evening

XALATAN®

NCI Common Terminology Criteria for Adverse Events

Assessment report for Xalatan and associated names

Shaare Zedek Medical Center

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

Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug in Patients With Open Angle Early Visual Field Defects Glaucoma or Ocular Hypertension in Comparison to Xalatan © Eye Drops in the Second Eye

Main Adverse Event that will be focused on during the study:
Irritation and local discomfort
Increased Lacrimation
Increased mucus
Intraocular inflammation
Ocular redness
Eyelid Edema
Hyperaemia conjunctival erythema
Keratitis

Tolerability will be evaluated on the basis of withdrawal rates over time.

Endpoints will be IOP differences from baseline of:
i. The plug inserted eye compared to the controlled treated eye at all study follow-up visits ii. The plug inserted eye at all study follow-up visits

IPD is not intended to be shared as this will be a single site study. The study will be public at ClinicalTrial.gov

The study is a prospective, open-label, controlled non-randomized study, comparative "split body"-design study comparing unilateral Latanoprost-loaded punctual plug in patients with open angle early visual field defects glaucoma or ocular hypertension with Xalatan © eye drops treatment in the second eye.

3% Diquafosol Tetrasodium Ophthalmic Solution

0.1% Sodium Hyaluronate Ophthalmic Solution

3% Diquafosol Tetrasodium Ophthalmic Solution
Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

Diqufosol

0.1% Sodium Hyaluronate Ophthalmic Solution
Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Hyaluronate

Total

Sex: Female, Male

Obstructive Meibomian Gland Dysfunction (MGD)

scale ranges (0-100). Higher values represent a worse outcome.

Ocular Surface Disease Index ± SD

tear Break-Up Time ± SD

Schirmer test ± SD

Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).
0 : best score (no corneal damage) 15 : worst score (severe corneal damages)

Fluorescein staining score ± SD

Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).
0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)

Lissamine green staining score ± SD

Total High Order Aberration (HOA) changes ± SD

Uncorrected visual acuity (LogMAR) ± SD

Grade ranges (0-4+), Evaluate cells using slit-lamp biomicroscopy. The slit beam should be 1mm x 1mm.
Grade 0 : < 1 cell in field, Grade 0.5+ : 1-5 cells in field, Grade 1+ : 6-15 cells in field, Grade 2+ : 16-25 cells in fields Grade 3+ : 26-50 cells in field, Grade 4+ : 50+ cells in fields

Grade of anterior chamber cells

The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.

an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.

Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.

Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.

Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.

Changes in HOAs After Blinking That is Related to Dry Eye Severity.

TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.

Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.

Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).
0 : best score (no corneal damage) 15 : worst score (severe corneal damages)

Corneal Fluorescein Staining That is Related to Dry Eye Severity.

Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).
0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)

Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity

Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.
grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam

Grades of Anterior Chamber Cells.

Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.

Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort

Overall Study

Dr. JinKwon Chung

Dry Eye Syndromes

Diquafosol group used diquafosol 6 times a day during study period.

Diquafosol (Diquas)

Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Sodium Hyaluronate (Hyalein)

Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial

Jin Kwon Chung

Assistant Professor, Cornea & Refractive Surgery Service, Department of Ophthalmology

Soonchunhyang University Hospital

Blepharitis

povidone iodine

Povidone-Iodine

Azithromycin

tobramycin-dexmethasone

Veterans Affairs Long Beach Healthcare System

Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Variables of interest will include:
A. Subjective Measures including patient-rated symptom scores for 1. Itching (grade 0-3) 2. foreign body sensation (grade 0-3) 3. ocular dryness (grade 0-3) 4. ocular burning (grade 0-3) and 5. swollen eyelids (grade 0-3) B. Objective Measures: Evaluation of 1. lid margin redness (grade 0-3) 2. meibomian gland plugging (grade 0-3) and 3. Presence of collarets and scurfs (Grade 0-3) 4. Cultures of eyelid margin at the start and at the conclusion of treatment at 10 days.

blepharitis/ödem

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

Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Herpetic Eye Disease Study (HEDS) II

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