POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma

NCT02466399 | Completed Phase 2 Results

• 1 other identifier: LipoLat-CS202
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized, multi-center, active-controlled parallel-comparison of POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary open-angle glaucoma.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months

  The mean change from baseline intraocular pressure at 3 months (0800 hrs)

  3 months

Study Arms (2)

POLAT-001

EXPERIMENTAL

Latanoprost liposome ophthalmic injection

Drug: POLAT-001

Latanoprost ophthalmic solution

ACTIVE COMPARATOR

latanoprost ophthalmic solution 0.005%

Drug: Latanoprost ophthalmic solution

Interventions

POLAT-001 DRUG

Subconjunctival injection

POLAT-001

Latanoprost ophthalmic solution DRUG

Latanoprost ophthalmic solution q.d., evening

Latanoprost ophthalmic solution

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year of age or greater.
• Diagnosis of primary open angle glaucoma (OAG) or ocular hypertension (OHT).
• Unmedicated (post-washout) intraocular pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart. If both eyes meet the IOP criteria, the eye with the higher IOP at Visit 1 will be designated as the study eye. If IOP in both eyes is the same, the right eye will be designated as the study eye. Note that both eyes will be treated.
• Corrected visual acuity at Visit -1 in each eye +1.0 logarithm of minimum angle of resolution (logMAR) or better by Early Treatment of Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200).
• Able and willing to give signed informed consent and follow study instructions.
• Subjects must have a documented history of ≥ 20% IOP reduction O.U. using any topical ocular prostaglandin/prostamide ocular hypotensive medication.

You may not qualify if:

• Ophthalmic
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles judged to be occludable by the investigator. Note: Previous laser peripheral iridotomy is NOT acceptable.
• IOP \> 36 mm Hg in either eye at any pre-randomization study visit.
• Known corticosteroid-responder as judged by investigator.
• Known hypersensitivity to any component of the Investigational Product formulation (benzalkonium chloride, etc.), fluoroquinolone ophthalmic solution, or topical anesthetics, Povidone Iodine antiseptic, or diagnostic eye drops.
• Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
• Refractive surgery in either eye .
• Ocular trauma, extraocular or intraocular surgery or laser treatment within the past six months in either eye.
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis in either eye. Note: mild blepharitis, allergy and dry eye is acceptable.
• Ocular medication of any kind within 30 days of Visit 1 in either eye, with the exception of a) ocular hypotensive therapy (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
• Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis sicca) in either eye which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe by the investigator (i.e., cup-disc ratio \> 0.8).
• Central corneal thickness greater than 600 µm in either eye.
• Any ocular abnormality preventing reliable applanation tonometry of either eye.
• Significant media opacity in either eye that would exclude adequate posterior segment examination
• Contraindications to pupil dilation in either eye.

Sponsors & Collaborators

• Peregrine Ophthalmic: lead

Study Sites (1)

Professional Research Network

Goose Creek, South Carolina, 29445, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Peregrine Ophthalmic Pte Ltd

jchua@peregrineop.com

65 97914382

Study Officials

• Tina T Wong, MD, Ph.D.

  Peregrine Ophthalmic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-09

Locations

US (1)