Allergic Conjunctivitis
Conditions
Keywords
ocular safety, allergic conjunctivitis
Brief summary
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
Interventions
Inactive ingredients used as placebo
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able and willing to comply with study protocol and follow protocol instructions. * Adequate birth control methods for the duration of the study. * Best-corrected visual acuity (BCVA) of 55 or greater in each eye. * Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration. * Willing and able to sign an Informed Consent form. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC). * Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1. * Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1. * Current or past history of glaucoma or ocular hypertension. * History of retinal detachment, diabetic retinopathy, or progressive retinal disease. * Presence of ocular conditions that may affect the study outcomes. * Corneal conditions affecting the corneal structure. * History or evidence of any ocular surgical procedure within 1 year prior to Visit 1. * Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study. * Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation. * Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study. * Known contraindications or hypersensitivities to any of the study medications or their components. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | An average of 6 weeks | An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. |
Participant flow
Recruitment details
Subjects were recruited from 15 study centers located in the United States.
Pre-assignment details
Of the 518 enrolled subjects, 18 subjects were exited from the study as screen failures. This reporting group includes all randomized subjects.
Participants by arm
| Arm | Count |
|---|---|
| AL-4943A AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks | 330 |
| AL-4943A Vehicle AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks | 169 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Randomized in error | 1 | 0 |
Baseline characteristics
| Characteristic | AL-4943A | Total | AL-4943A Vehicle |
|---|---|---|---|
| Age, Customized 12-17 years | 4 participants | 7 participants | 3 participants |
| Age, Customized 18-64 years | 272 participants | 413 participants | 141 participants |
| Age, Customized 2-11 years | 47 participants | 68 participants | 21 participants |
| Age, Customized ≥65 years | 7 participants | 11 participants | 4 participants |
| Sex: Female, Male Female | 214 Participants | 325 Participants | 111 Participants |
| Sex: Female, Male Male | 116 Participants | 174 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 330 | 0 / 169 |
| serious Total, serious adverse events | 0 / 330 | 0 / 169 |
Outcome results
Primary
Adverse Events
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Time frame: An average of 6 weeks
Population: This reporting group includes all randomized subjects who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AL-4943A | Adverse Events | Non-Fatal Serious Adverse Events | 0 participants |
| AL-4943A | Adverse Events | Discontinuations Due to an Adverse Event | 0 participants |
| AL-4943A | Adverse Events | Deaths | 0 participants |
| AL-4943A Vehicle | Adverse Events | Non-Fatal Serious Adverse Events | 0 participants |
| AL-4943A Vehicle | Adverse Events | Deaths | 0 participants |
| AL-4943A Vehicle | Adverse Events | Discontinuations Due to an Adverse Event | 2 participants |