Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01999764

Enrollment

Registered

2013-12-03

Start date

2013-11-30

Completion date

2014-07-31

Last updated

2015-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Dark Adaptation

Brief summary

This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.

Detailed description

This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation. Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.

Interventions

DRUGQLT091001

QLT091001 administered orally at multiple time points.

OTHERPlacebo

Placebo is administered orally at multiple time points.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation * Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye * Capable and willing to provide consent

Exclusion criteria

* Women of child bearing potential * Subjects with late AMD or any other optic neuropathy in the study eye * Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye * Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0 * Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity	Through 7 weeks	Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.

Secondary

Measure	Time frame	Description
Dark Adaptation Time	Through 7 weeks	Dark Adaptation Time will be measured at multiple time points.

Other

Measure	Time frame	Description
Glare Recovery	Through 7 weeks	Glare recovery time will be measured at multiple time points.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026