NCT00489398

Brief Summary

Comparison of two allergy drops for enhancing comfort and performance of contact lens wear

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2007

Status
withdrawn

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

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

First QC Date

June 19, 2007

Last Update Submit

October 5, 2010

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Contact lens objective and subjective clinical performance testing

    up to 3 months

Interventions

epinastine HCL and olopatadine HCLDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females \> 18 years old
  • Mild to moderate dry eye symptoms
  • Likely to complete all study visits and able to provide informed consent

You may not qualify if:

  • Current use of topical cyclosporine
  • Known contraindications to any study medication or ingredients
  • Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
  • Ocular surgery within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

epinastineOlopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Milton M Hom, OD FAAO

    Private Practice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

July 1, 2007

Study Completion

December 1, 2008

Last Updated

October 7, 2010

Record last verified: 2010-10