Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Sponsor
Eye Therapies, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01675609
Collaborator
(none)
57
1
2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
Study Start Date
:
Aug 1, 2012
Actual Primary Completion Date
:
Oct 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
1 drop in each eye daily for up to 35 days
|
| Experimental: Brimonidine Tartrate 0.025%
|
Drug: Brimonidine tartrate 0.025%
1 drop in each eye for up to 35 days
|
Outcome Measures
Primary Outcome Measures
- Ocular redness [at specified timepoints for up to 180 minutes]
redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary
Secondary Outcome Measures
- Ocular Redness [up to 5 minutes post study medication instillation]
evaluated prior to study medication instillation and at 5 minutes post instillation
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Be at least 40 years of age
-
Must have normal ocular health
-
Must have history of redness relief drop use or desire to use
Exclusion Criteria:
-
Must not have any ocular/systemic health problems
-
Must agree to avoid disallowed medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ora, Inc. | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- Eye Therapies, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eye Therapies, LLC
ClinicalTrials.gov Identifier:
NCT01675609
Other Study ID Numbers:
- 11-100-0015
First Posted:
Aug 30, 2012
Last Update Posted:
Jul 31, 2014
Last Verified:
Jul 1, 2014