A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months

NCT01699464 | Completed Phase 2

• 1 other identifier: AR-12286-CS206
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

Brief Summary

A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.

Conditions

Ocular Hypertension; Open-angle Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3

  Intraocular pressure

  Month 3

Study Arms (3)

AR-12286 Ophthalmic Solution 0.7%

EXPERIMENTAL

AR-12286 Ophthalmic Solution 0.7%, both eyes

Drug: AR-12286 Ophthalmic Solution 0.7%

AR-12286 Ophthalmic Solution 0.5%

EXPERIMENTAL

AR-12286 Ophthalmic Solution 0.5% both eyes

Drug: AR-12286 Ophthalmic Solution 0.5%

Timolol maleate ophthalmic solution 0.5%

ACTIVE COMPARATOR

Timolol maleate ophthalmic solution 0.5% both eyes

Drug: Timolol maleate ophthalmic solution 0.5%

Interventions

AR-12286 Ophthalmic Solution 0.7% DRUG

Ophthalmic Solution

AR-12286 Ophthalmic Solution 0.7%

AR-12286 Ophthalmic Solution 0.5% DRUG

Ophthalmic Solution

AR-12286 Ophthalmic Solution 0.5%

Timolol maleate ophthalmic solution 0.5% DRUG

Ophthalmic Solution

Timolol maleate ophthalmic solution 0.5%

Eligibility Criteria

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

You may qualify if:

• year of age or greater. (India\_ Maximum age of 65 years)
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
• Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart, and ≥ 22 mm Hg at 1000 and 1600 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
• Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
• Able and willing to give signed informed consent and follow study instructions.

You may not qualify if:

• Ophthalmic
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
• IOP \> 36 mm Hg
• Current use of more than 1 ocular hypotensive medications (Note: fixed dose combinations are considered multiple medications).
• Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
• Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
• Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
• Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis
• Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (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) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio \> 0.8).
• Central corneal thickness greater than 600 µm.
• Any abnormality preventing reliable applanation tonometry of either eye.
• Systemic:
• Systemic:

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Brian Levy, OD

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 3, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 22, 2023

Record last verified: 2023-08