A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02792803
• Date of registration: 31/05/2016
• Prospective Registration: No
• Primary sponsor: Dr. David Yan
• Public title: A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
• Scientific title: An 8 Week Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Open Angle Glaucoma
• Date of first enrolment: September 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02792803
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Jonathan Elin-Calcador

• Name: David B Yan, M.D., F.R.C.S. (C)
• Affiliation: Ophthalmic Diagnostic Services

• Name: Jonathan Elin-Calcador

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients = 18 years old, diagnosed with primary open angle glaucoma or ocular
hypertension

- IOP currently controlled on prostaglandin analogue monotherapy (latanoprost,
bimatoprost or travoprost), as judged by the investigator

Exclusion Criteria:

- Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.

- Patients in whom the mean IOP in either eye at the screening exam visit is greater
than 36 mmHg

- History of ocular trauma within the past six (6) months.

- History of ocular infection or ocular inflammation within the past three (3) months.

- History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis,
uveitis)

- History of severe or serious hypersensitivity to any components of the study
medications.

- Any abnormality preventing reliable applanation tonometry of either eye.

- Intraocular surgery within the past six (6) months as determined by patient history
and/or examination.

- Patients with cup/disc ratio greater than 0.80 in either eye.

- Patients with severe central visual field loss in either eye defined as a sensitivity
less than or equal to 10 dB in at least two (2) of the four (4) visual field test
points closest to the point of fixation. Visual field test must be within 6 months of
eligibility assessment.

- History of clinically significant or progressive retinal disease such as retinal
degeneration, diabetic retinopathy or retinal detachment.

- Current use of ANY glucocorticoid administered by any route. Patient must have washed
out of the glucocorticoid for at least 4 weeks prior to study entry.

- Use of any systemic prostaglandin or prostaglandin analogue within the last three
months.

- Current use of topical non-steroidal antiinflammatory agents which inhibit
cyclo-oxygenase and prostaglandin analogue synthesis.

- Any form of glaucoma other than open-angle glaucoma (with or without a pigment
dispersion or pseudoexfoliation component).

- Current use of topical non-steroidal anti inflammatory agents which inhibit
cyclo-oxygenase and prostaglandin analogue synthesis.

- Angle grade less than 2 (extreme narrow angle with complete or partial closure) as
measured by gonioscopy.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

POAG

Primary Open Angle Glaucoma

Ocular Hypertension

Intervention(s)

Drug: Apo-Latanoprost

Drug: Xalatan

Drug: Co-Latanoprost

Primary Outcome(s)

Intraocular Pressure [Time Frame: 4 weeks]

Secondary Outcome(s)

Ocular Hyperemia [Time Frame: 4 weeks]

Secondary ID(s)

Pro00012759

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Allergan