Study Stopped
Formula Reformulation
Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2014
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
August 6, 2012
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedOctober 2, 2018
October 1, 2018
5 months
July 19, 2012
October 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
conjunctival hyperemia
Change from Baseline in conjunctival hyperemia after 21 days of treatment
day 21
Secondary Outcomes (1)
epiphora
day 21
Other Outcomes (2)
green lissamine dye
day 21
fluorescein dye
day 21
Study Arms (2)
PRO-118
EXPERIMENTALpro-118 ophthalmic solution, instill one drop in each eye once a day for 21 days
Olopatadine Hydrochloride
ACTIVE COMPARATOROlopatadine Hydrochloride ophthalmic solution 2%, instill one drop in each eye once a day for 21 days
Interventions
instill one drop in each eye once a day for 21 days
instill one drop in each eye once a day for 21 days
Eligibility Criteria
You may qualify if:
- Provide informed consent
- Allergic conjunctivitis diagnosis
- Both genders
- Age between 6 and 60 years
You may not qualify if:
- Patients with one blind eye
- Visual acuity \< 20/40 in any eye
- Patients with any active ocular disease that would interfere with study interpretation
- Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
- Patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer
- Patients with history of hypersensitivity or contraindication for any drug used in the study
- Patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients without birth control treatment
- Patients who had participated in any clinical trial in the last 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
August 6, 2012
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
October 2, 2018
Record last verified: 2018-10