A Six-Week Safety Study of an Investigational Ophthalmic Solution
Status: | Completed |
---|---|
Conditions: | Allergy, Ocular |
Therapuetic Areas: | Ophthalmology, Otolaryngology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | October 2012 |
End Date: | March 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-241-7629 |
The purpose of this study is 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.
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 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.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Females: Pregnant, nursing, planning pregnancy, not using adequate birth control.
- 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-defined exclusion criteria may apply.
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