Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01426464
• Date of registration: 27/08/2011
• Primary sponsor: Nanduri, Padma, M.D., FACS
• Public title: Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
• Scientific title: Phase 2 Study of Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Latanoprost Therapy
• Date of first enrolment: September 2011
• Target sample size: 22
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01426464
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael Boone, MD

• Name: Padma Nanduri, MD

• Name: Padma Nanduri, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable
Vital signs who are controlled on a stable dose of a single IOP lowering agent and
who have demonstrated stable target intraocular pressure for a minimum of 3 months.

- Male or Female patients aged at least 18 years of age.

- Females of childbearing potential must use a reliable form of contraception
throughout the study period such as celibacy, birth control pills, or condoms.

- A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of
childbearing potential.

- Best-Corrected Visual Acuity of 20/800 or better in both eyes

- Written informed consent.

- Ability to follow instructions and likely to complete all study visits based upon
patient factors such as cognition, reliability, motivation, and ability to obtain
reliable transportation to study site.

Exclusion Criteria:

- Uncontrolled glaucoma

- Glaucoma requiring more than a single agent for IOP control

- Patients with a corneal thickness greater then 620 micrometers

- Female patients who are pregnant, nursing, or planning a pregnancy during the study

- Patient who has any situation or condition, which in the investigator's opinion, may
put the patient at a significant risk, may confound the study result or may interfere
significantly with the participation in the study

- Active intraocular inflammation

- Cystoid Macular Edema



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glaucoma

Intervention(s)

Drug: 0.005% Latanoprost dosed once.

Primary Outcome(s)

Intraocular Pressure [Time Frame: Day nine, once.]

Intraocular Pressure [Time Frame: Day one, every hour for twelve hours.]

Intraocular Pressure [Time Frame: Day sixteen, once.]

Intraocular Pressure [Time Frame: Day thirty, once.]

Intraocular Pressure [Time Frame: Day twenty three, once.]

Intraocular Pressure [Time Frame: Day two twice, once in the AM, once in the PM.]

Secondary ID(s)

Brown Rabbit 2011-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors