A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

NCT03198000 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CO-161103095739-VCCT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

Conditions

Ophthalmic Solutions

Keywords

Eye Redness; Eye Comfort; Red Eyes

Outcome Measures

Primary Outcomes (2)

• Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application

  Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

  Baseline to 60 seconds after first product application

• Percentage of Participants With Response to Redness at 60 Seconds After First Product Application

  The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

  Baseline to 60 seconds after first product application

Secondary Outcomes (32)

• Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application

  Baseline to 30 seconds after first product application

• Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application

  Baseline to 2 minutes after first product application

• Clinician Assessment of Baseline Redness

  Baseline

• Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application

  Baseline to 60 seconds after first product application

• Change From Baseline in Ocular Comfort at 10 Hours After First Product Application

  Baseline to 10 hours after first product application

Study Arms (3)

Formula # 13418-148

EXPERIMENTAL

Drug: F# 13418-148 Eye Drops

Formula # 13418-158

EXPERIMENTAL

Drug: F#13418-158 Eye Drops

Control Formula # PF004390

ACTIVE COMPARATOR

Drug: F# PF-004390 Eye Drops

Interventions

F# 13418-148 Eye Drops DRUG

ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day

Formula # 13418-148

F#13418-158 Eye Drops DRUG

ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day

Formula # 13418-158

F# PF-004390 Eye Drops DRUG

Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day

Control Formula # PF004390

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
• Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
• Male or female of any race or ethnicity, aged 18 years and older;
• Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
• Able to read and understand English;
• Healthy subjects with redness in both eyes
• History of topical ocular drugs or desire to use within the last 6 months;
• Ocular health within normal limits,
• Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

You may not qualify if:

• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
• Known sensitivity, allergy or contraindications to any investigational product ingredient;
• Females who are pregnant, planning to become pregnant or breastfeeding during the study;
• Subjects who were previously screened and determined to be ineligible for the study;
• Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
• Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
• Relative, partner or staff of any clinical research site personnel;
• Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
• Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
• Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
• Has a compromised immune system;
• Has any acute or chronic, medical or psychiatric conditions
• Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
• Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
• Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Related Publications (3)

• Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44.

  PMID: 20082509 BACKGROUND

• Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.

  PMID: 8961843 BACKGROUND

• Murphy PJ, Lau JS, Sim MM, Woods RL. How red is a white eye? Clinical grading of normal conjunctival hyperaemia. Eye (Lond). 2007 May;21(5):633-8. doi: 10.1038/sj.eye.6702295. Epub 2006 Mar 3.

  PMID: 16518366 BACKGROUND

Results Point of Contact

• Title: Amisha Parikh-Das, PhD, MPH
• Organization: Johnson & Johnson Consumer Inc.

AParikh1@its.jnj.com

(973) 255-8701

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 22, 2017
• First Posted: June 23, 2017
• Study Start: June 28, 2017
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: May 24, 2023
• Results First Posted: August 8, 2018

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)