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Prostaglandin Analog

Patients taking Xalatan with ocular dryness or irritation for Ocular Hypertension

N/A
Waitlist Available
Led By James R Townley, MD
Research Sponsored by United States Air Force
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many studies have demonstrated that prolonged use of topical ocular medications preserved with BAC may exacerbate sequelae associated with ocular surface disease. These effects could lead to the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function, 2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher incidence of patient complaints of dryness and irritation. 4-6 This study will compare the efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess whether those two different formulations will affect the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results.

Eligible Conditions
  • Ocular Hypertension
  • Eye Irritation
  • Open-Angle Glaucoma
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Eyelids pruritus
1%
Pharyngitis
1%
Eye irritation
1%
Blepharal pigmentation
1%
Cataract
1%
Conjunctivitis allergic
1%
Acute tonsillitis
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients taking Xalatan with ocular dryness or irritationExperimental Treatment1 Intervention
* patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation. * any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latanoprost
FDA approved

Find a Location

Who is running the clinical trial?

United States Air ForceLead Sponsor
19 Previous Clinical Trials
52,148 Total Patients Enrolled
Alcon ResearchIndustry Sponsor
731 Previous Clinical Trials
128,876 Total Patients Enrolled
106 Trials studying Ocular Hypertension
21,904 Patients Enrolled for Ocular Hypertension
James R Townley, MDPrincipal InvestigatorUnited States Air Force
~2 spots leftby Nov 2025