Clinical trial NCT03198000: A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Official title: A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ophthalmic Solutions
Keywords: Eye Redness
Eye Comfort
Red Eyes
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
3. Male or female of any race or ethnicity, aged 18 years and older;
4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
5. Able to read and understand English;
6. Healthy subjects with redness in both eyes
7. History of topical ocular drugs or desire to use within the last 6 months;
8. Ocular health within normal limits,
9. 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.

Exclusion Criteria:

1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
2. Known sensitivity, allergy or contraindications to any investigational product ingredient;
3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;
4. Subjects who were previously screened and determined to be ineligible for the study;
5. 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;
6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
7. Relative, partner or staff of any clinical research site personnel;
8. 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;
9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
11. Has a compromised immune system;
12. Has any acute or chronic, medical or psychiatric conditions
13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Primary outcomes:
measure: Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application
timeFrame: Baseline to 60 seconds after first product application
measure: Percentage of Participants With Response to Redness at 60 Seconds After First Product Application
timeFrame: Baseline to 60 seconds after first product application
Secondary outcomes:
measure: Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application
timeFrame: Baseline to 30 seconds after first product application
measure: Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application
timeFrame: Baseline to 2 minutes after first product application
measure: Clinician Assessment of Baseline Redness
timeFrame: Baseline
measure: Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application
timeFrame: Baseline to 60 seconds after first product application
measure: Change From Baseline in Ocular Comfort at 10 Hours After First Product Application
timeFrame: Baseline to 10 hours after first product application
measure: Change From Baseline in Ocular Comfort at 12 Hours After First Product Application
timeFrame: Baseline to 12 hours after first product application
measure: My Eye Feels Hydrated - Baseline
timeFrame: Baseline
measure: My Eye Feels Hydrated - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: My Eye Feels Hydrated - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: My Eye Feels Hydrated - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: My Eye Feels Refreshed - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: My Eye Feels Refreshed - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: My Eye Feels Refreshed - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: The Appearance of my Eye Gives me Confidence to Approach Others - Baseline
timeFrame: Baseline
measure: The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: The Appearance of my Eye Can Show How I Really Feel - Baseline
timeFrame: Baseline
measure: The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: My Eye Appears Healthy - Baseline
timeFrame: Baseline
measure: My Eye Appears Healthy - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: My Eye Appears Healthy - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: My Eye Appears Healthy - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: My Eye Feels Cool - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: My Eye Feels Cool - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: My Eye Feels Cool - 12 Hours After First Application
timeFrame: 12 hours after first application
measure: My Eye Appears to Sparkle - Baseline
timeFrame: Baseline
measure: My Eye Appears to Sparkle - 2 Minutes After First Application
timeFrame: 2 minutes after first application
measure: My Eye Appears to Sparkle - 10 Hours After First Application
timeFrame: 10 hours after first application
measure: My Eye Appears to Sparkle - 12 Hours After First Application
timeFrame: 12 hours after first application
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.
citation: 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.