Efficacy and Safety Study of FID 119515A

NCT ID: NCT01833117

Last Updated: 2018-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FID 119515A

FID 119515A, 1 drop instilled in the study eye, single dose

Group Type EXPERIMENTAL

FID 119515A

Intervention Type OTHER

topical ocular drops

Blink

Blink® Tears, 1 drop instilled in the study eye, single dose

Group Type ACTIVE_COMPARATOR

Blink® Tears

Intervention Type OTHER

topical ocular drops

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FID 119515A

topical ocular drops

Intervention Type OTHER

Blink® Tears

topical ocular drops

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Sign Informed Consent.
* Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
* At least a 3 month documented history of dry eye in both eyes.
* TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.

Exclusion Criteria

* Pregnant or breastfeeding.
* Any evidence of ocular infection or inflammation within 30 days prior to Screening.
* Any ocular surgery.
* Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
* Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
* Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
* Participation in any other clinical trial within 30 days prior to Screening.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa Lindsey, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-12-021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of NOV03 on the Tear Film
NCT05723770 COMPLETED PHASE4
Evaluation of Reflex Tear Production
NCT06565624 TERMINATED NA
Dry Eye Disease Study With Brimonidine
NCT03418727 COMPLETED PHASE2